Trial Outcomes & Findings for A Dose-finding Study of the Bromodomain (Brd) Inhibitor OTX015/ Birabresib (MK-8628) in Hematologic Malignancies (MK-8628-001) (NCT NCT01713582)
NCT ID: NCT01713582
Last Updated: 2021-01-26
Results Overview
A DLT was graded using the National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.02 and defined as any of the following: grade 3 or 4 non-hematologic adverse events unless they were not optimally treated with supportive care; grade 3 or 4 asymptomatic laboratory abnormal values lasting \>7 days; prolonged grade 2 toxicity (lasting more than 2 weeks) leading to treatment interruption and/or dose reduction; pancytopenia with a hypocellular bone marrow and no marrow blasts lasting ≥6 weeks (AL participants); grade 3 neutropenia with fever or infection (OHM participants); grade 3 thrombocytopenia with bleeding (OHM participants); or grade 4 neutropenia or thrombocytopenia, regardless of symptoms and lasting ≥3 days (OHM participants).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
141 participants
Primary outcome timeframe
Cycle 1 (Up to 21 days)
Results posted on
2021-01-26
Participant Flow
80 participants were enrolled in the acute leukemia (AL) cohort and 78 were treated. 61 participants were enrolled in the other hematological malignancies (OHM) cohort and 60 were treated.
The study consisted of a dose escalation phase in participants with AL and OHM followed by and expansion phase in 3 cohorts: de novo acute myelocytic leukemia (AML), myelodysplastic syndrome (MDS) AML, and diffuse large B-cell lymphoma (DLBCL).
Participant milestones
| Measure |
AL 20 mg QD 14-21
Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 40 mg QD 14-21
Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 10 mg QD 14-21
Participants received 10 mg MK-8628/OTX015 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 20 mg BID 21-21
Participants received 20 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
|
AL 80 mg QD 14-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 40 mg BID 14-21
Participants received 40 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.
|
AL 120 mg QD 14-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 120 mg QD 21-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
AL 160 mg QD 14-21
Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AML de Novo 80 mg QD 14-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AML/MDS 80 mg QD 14-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
OHM 10 mg QD 21-21
Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 20 mg QD 21-21
Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 40 mg QD 21-21
Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 80 mg QD 21-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 40 mg BID 21-21
Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
|
OHM 120 mg QD 21-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 120 mg QD 14-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
OHM 120 mg QD 5-7
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 5 of a 7-day cycle.
|
OHM 120 mg QD 7-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 7 of a 21-day cycle.
|
OHM/DLBCL 80 mg QD 14-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
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4
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3
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3
|
4
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8
|
7
|
6
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6
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18
|
16
|
5
|
3
|
4
|
7
|
6
|
7
|
3
|
5
|
5
|
15
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
3
|
3
|
4
|
8
|
7
|
6
|
6
|
18
|
16
|
5
|
3
|
4
|
7
|
6
|
7
|
3
|
5
|
5
|
15
|
Reasons for withdrawal
| Measure |
AL 20 mg QD 14-21
Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 40 mg QD 14-21
Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 10 mg QD 14-21
Participants received 10 mg MK-8628/OTX015 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 20 mg BID 21-21
Participants received 20 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
|
AL 80 mg QD 14-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 40 mg BID 14-21
Participants received 40 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.
|
AL 120 mg QD 14-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 120 mg QD 21-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
AL 160 mg QD 14-21
Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AML de Novo 80 mg QD 14-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AML/MDS 80 mg QD 14-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
OHM 10 mg QD 21-21
Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 20 mg QD 21-21
Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 40 mg QD 21-21
Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 80 mg QD 21-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 40 mg BID 21-21
Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
|
OHM 120 mg QD 21-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 120 mg QD 14-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
OHM 120 mg QD 5-7
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 5 of a 7-day cycle.
|
OHM 120 mg QD 7-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 7 of a 21-day cycle.
|
OHM/DLBCL 80 mg QD 14-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Disease progression
|
3
|
3
|
3
|
2
|
3
|
3
|
3
|
3
|
3
|
11
|
10
|
5
|
3
|
3
|
6
|
6
|
5
|
2
|
3
|
5
|
15
|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
1
|
3
|
3
|
2
|
3
|
4
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse event-related
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse event-unrelated
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal of consent
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Stopped to receive bone marrow graft
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Disease progression and adverse event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
AL 10 mg QD 14-21
n=3 Participants
Participants received 10 mg MK-8628/OTX015 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 20 mg QD 14-21
n=3 Participants
Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 40 mg QD 14-21
n=4 Participants
Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 20 mg BID 21-21
n=3 Participants
Participants received 20 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
|
AL 80 mg QD 14-21
n=4 Participants
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 40 mg BID 14-21
n=8 Participants
Participants received 40 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.
|
AL 120 mg QD 14-21
n=7 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 120 mg QD 21-21
n=6 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
AL 160 mg QD 14-21
n=6 Participants
Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AML de Novo 80 mg QD 14-21
n=18 Participants
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AML/MDS 80 mg QD 14-21
n=16 Participants
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
OHM 10 mg QD 21-21
n=5 Participants
Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 20 mg QD 21-21
n=3 Participants
Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 40 mg QD 21-21
n=4 Participants
Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 80 mg QD 21-21
n=7 Participants
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 40 mg BID 21-21
n=6 Participants
Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
|
OHM 120 mg QD 21-21
n=7 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 120 mg QD 14-21
n=3 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
OHM 120 mg QD 5-7
n=5 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 5 of a 7-day cycle.
|
OHM 120 mg QD 7-21
n=5 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 7 of a 21-day cycle.
|
OHM/DLBCL 80 mg QD 14-21
n=15 Participants
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
Total
n=138 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
67.0 Years
STANDARD_DEVIATION 3.5 • n=3 Participants
|
54.7 Years
STANDARD_DEVIATION 19.6 • n=3 Participants
|
73.8 Years
STANDARD_DEVIATION 2.1 • n=4 Participants
|
77.7 Years
STANDARD_DEVIATION 2.3 • n=3 Participants
|
70.0 Years
STANDARD_DEVIATION 10.6 • n=4 Participants
|
65.8 Years
STANDARD_DEVIATION 16.3 • n=8 Participants
|
65.3 Years
STANDARD_DEVIATION 13.9 • n=7 Participants
|
58.5 Years
STANDARD_DEVIATION 24.1 • n=6 Participants
|
57.8 Years
STANDARD_DEVIATION 16.6 • n=6 Participants
|
65.6 Years
STANDARD_DEVIATION 10.0 • n=18 Participants
|
67.2 Years
STANDARD_DEVIATION 8.2 • n=16 Participants
|
65.2 Years
STANDARD_DEVIATION 15.5 • n=5 Participants
|
74.7 Years
STANDARD_DEVIATION 7.4 • n=3 Participants
|
69.0 Years
STANDARD_DEVIATION 8.4 • n=4 Participants
|
59.4 Years
STANDARD_DEVIATION 18.5 • n=7 Participants
|
54.7 Years
STANDARD_DEVIATION 13.0 • n=6 Participants
|
55.6 Years
STANDARD_DEVIATION 19.3 • n=7 Participants
|
66.0 Years
STANDARD_DEVIATION 13.2 • n=3 Participants
|
62.4 Years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
66.8 Years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
58.5 Years
STANDARD_DEVIATION 14.1 • n=15 Participants
|
63.7 Years
STANDARD_DEVIATION 13.6 • n=138 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
8 Participants
n=18 Participants
|
3 Participants
n=16 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=15 Participants
|
46 Participants
n=138 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=8 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
10 Participants
n=18 Participants
|
13 Participants
n=16 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=3 Participants
|
5 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
11 Participants
n=15 Participants
|
92 Participants
n=138 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Cycle 1 (Up to 21 days)Population: All participants who received at least 85% of the intended dose of study therapy during the first cycle (i.e. \>12 days at full dose for AL and \>18 days at full dose for other hematological malignancies) or discontinued from the study due to a DLT attributable to study therapy.
A DLT was graded using the National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.02 and defined as any of the following: grade 3 or 4 non-hematologic adverse events unless they were not optimally treated with supportive care; grade 3 or 4 asymptomatic laboratory abnormal values lasting \>7 days; prolonged grade 2 toxicity (lasting more than 2 weeks) leading to treatment interruption and/or dose reduction; pancytopenia with a hypocellular bone marrow and no marrow blasts lasting ≥6 weeks (AL participants); grade 3 neutropenia with fever or infection (OHM participants); grade 3 thrombocytopenia with bleeding (OHM participants); or grade 4 neutropenia or thrombocytopenia, regardless of symptoms and lasting ≥3 days (OHM participants).
Outcome measures
| Measure |
AL 10 mg QD 14-21
n=3 Participants
Participants received 10 mg MK-8628/OTX015 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 20 mg QD 14-21
n=3 Participants
Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 40 mg QD 14-21
n=4 Participants
Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 20 mg BID 21-21
n=3 Participants
Participants received 20 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
|
AL 80 mg QD 14-21
n=4 Participants
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 40 mg BID 14-21
n=6 Participants
Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.
|
AL 120 mg QD 14-21
n=6 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 120 mg QD 21-21
n=6 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
AL 160 mg QD 14-21
n=6 Participants
Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AML de Novo 80 mg QD 14-21
n=17 Participants
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AML/MDS 80 mg QD 14-21
n=14 Participants
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
OHM 10 mg QD 21-21
n=3 Participants
Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 20 mg QD 21-21
n=3 Participants
Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 40 mg QD 21-21
n=3 Participants
Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 80 mg QD 21-21
n=7 Participants
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 40 mg BID 21-21
n=6 Participants
Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
|
OHM 120 mg QD 21-21
n=6 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 120 mg QD 14-21
n=3 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
OHM 120 mg QD 5-7
n=4 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 5 of a 7-day cycle.
|
OHM 120 mg QD 7-21
n=5 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 7 of a 21-day cycle.
|
OHM/DLBCL 80 mg QD 14-21
n=14 Participants
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 40 days after last dose of study therapy (Up to 28 months)Population: All participants who received at least one dose of study therapy.
AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol specified procedure, whether or not considered related to the medicinal product/protocol specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. AEs were collected during the entire time frame of treatment plus up to 40 days of follow-up.
Outcome measures
| Measure |
AL 10 mg QD 14-21
n=3 Participants
Participants received 10 mg MK-8628/OTX015 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 20 mg QD 14-21
n=3 Participants
Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 40 mg QD 14-21
n=4 Participants
Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 20 mg BID 21-21
n=3 Participants
Participants received 20 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
|
AL 80 mg QD 14-21
n=4 Participants
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 40 mg BID 14-21
n=8 Participants
Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.
|
AL 120 mg QD 14-21
n=7 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 120 mg QD 21-21
n=6 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
AL 160 mg QD 14-21
n=6 Participants
Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AML de Novo 80 mg QD 14-21
n=18 Participants
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AML/MDS 80 mg QD 14-21
n=16 Participants
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
OHM 10 mg QD 21-21
n=5 Participants
Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 20 mg QD 21-21
n=3 Participants
Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 40 mg QD 21-21
n=4 Participants
Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 80 mg QD 21-21
n=7 Participants
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 40 mg BID 21-21
n=6 Participants
Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
|
OHM 120 mg QD 21-21
n=7 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 120 mg QD 14-21
n=3 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
OHM 120 mg QD 5-7
n=5 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 5 of a 7-day cycle.
|
OHM 120 mg QD 7-21
n=5 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 7 of a 21-day cycle.
|
OHM/DLBCL 80 mg QD 14-21
n=15 Participants
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced at Least One Adverse Event (AE)
|
3 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
8 Participants
|
7 Participants
|
6 Participants
|
6 Participants
|
18 Participants
|
16 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
7 Participants
|
6 Participants
|
7 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: From time of first dose of study therapy until the end of treatment (up to 26 months)Population: All participants who received at least one dose of study therapy.
All participants who discontinued study therapy due to an AE at any time during treatment.
Outcome measures
| Measure |
AL 10 mg QD 14-21
n=3 Participants
Participants received 10 mg MK-8628/OTX015 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 20 mg QD 14-21
n=3 Participants
Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 40 mg QD 14-21
n=4 Participants
Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 20 mg BID 21-21
n=3 Participants
Participants received 20 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
|
AL 80 mg QD 14-21
n=4 Participants
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 40 mg BID 14-21
n=8 Participants
Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.
|
AL 120 mg QD 14-21
n=7 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 120 mg QD 21-21
n=6 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
AL 160 mg QD 14-21
n=6 Participants
Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AML de Novo 80 mg QD 14-21
n=18 Participants
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AML/MDS 80 mg QD 14-21
n=16 Participants
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
OHM 10 mg QD 21-21
n=5 Participants
Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 20 mg QD 21-21
n=3 Participants
Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 40 mg QD 21-21
n=4 Participants
Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 80 mg QD 21-21
n=7 Participants
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 40 mg BID 21-21
n=6 Participants
Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
|
OHM 120 mg QD 21-21
n=7 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 120 mg QD 14-21
n=3 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
OHM 120 mg QD 5-7
n=5 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 5 of a 7-day cycle.
|
OHM 120 mg QD 7-21
n=5 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 7 of a 21-day cycle.
|
OHM/DLBCL 80 mg QD 14-21
n=15 Participants
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Therapy Due to AEs
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
7 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From time of first dose of study therapy until the end of treatment (up to 26 months)Population: All participants who received one dose of study therapy and had at least one available tumor assessment by the end of Cycle 2 or later or with earlier evidence of response or progression.
Best response was determined from the start of treatment until disease progression, recurrence, or completion of 26 months of treatment. Partial and complete response was assessed by bone marrow aspiration (AL participants); or computed tomography scan, magnetic resonance imaging, positron emission tomography, or X-ray (OHM participants) using standard criteria. Acute leukemia participants were assessed based on the recommendations from the European LeukemiaNet Döhner 2010); lymphoma participants according to Cheson 2007; and MM participants according to Durie 2006.
Outcome measures
| Measure |
AL 10 mg QD 14-21
n=3 Participants
Participants received 10 mg MK-8628/OTX015 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 20 mg QD 14-21
n=3 Participants
Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 40 mg QD 14-21
n=4 Participants
Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 20 mg BID 21-21
n=3 Participants
Participants received 20 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
|
AL 80 mg QD 14-21
n=4 Participants
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 40 mg BID 14-21
n=8 Participants
Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.
|
AL 120 mg QD 14-21
n=7 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 120 mg QD 21-21
n=6 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
AL 160 mg QD 14-21
n=6 Participants
Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AML de Novo 80 mg QD 14-21
n=18 Participants
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AML/MDS 80 mg QD 14-21
n=16 Participants
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
OHM 10 mg QD 21-21
n=5 Participants
Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 20 mg QD 21-21
n=3 Participants
Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 40 mg QD 21-21
n=4 Participants
Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 80 mg QD 21-21
n=7 Participants
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 40 mg BID 21-21
n=6 Participants
Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
|
OHM 120 mg QD 21-21
n=7 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 120 mg QD 14-21
n=3 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
OHM 120 mg QD 5-7
n=5 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 5 of a 7-day cycle.
|
OHM 120 mg QD 7-21
n=5 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 7 of a 21-day cycle.
|
OHM/DLBCL 80 mg QD 14-21
n=15 Participants
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Whose Best Response Was Partial Response (PR) or Complete Response (CR)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-infusion and 20 minutes; 1, 2.25, 3.25, 4, 6, 8, 9, 12, and 24 hours plus one sampling at either 10 hour or 16 hour post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion dependent on dose regimen and enrollment positionPopulation: All participants that received at least 1 dose of study therapy and had evaluable data for endpoint. Results were pooled by dose taken and not by disease or regimen.
Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24 hours (h) + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level. Blood samples for Cmax were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies.
Outcome measures
| Measure |
AL 10 mg QD 14-21
n=8 Participants
Participants received 10 mg MK-8628/OTX015 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 20 mg QD 14-21
n=6 Participants
Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 40 mg QD 14-21
n=8 Participants
Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 20 mg BID 21-21
n=3 Participants
Participants received 20 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
|
AL 80 mg QD 14-21
n=11 Participants
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 40 mg BID 14-21
n=13 Participants
Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.
|
AL 120 mg QD 14-21
n=31 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 120 mg QD 21-21
n=5 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
AL 160 mg QD 14-21
n=49 Participants
Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AML de Novo 80 mg QD 14-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AML/MDS 80 mg QD 14-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
OHM 10 mg QD 21-21
Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 20 mg QD 21-21
Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 40 mg QD 21-21
Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 80 mg QD 21-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 40 mg BID 21-21
Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
|
OHM 120 mg QD 21-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 120 mg QD 14-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
OHM 120 mg QD 5-7
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 5 of a 7-day cycle.
|
OHM 120 mg QD 7-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 7 of a 21-day cycle.
|
OHM/DLBCL 80 mg QD 14-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Concentration (Cmax) of MK-8628/OTX015
|
131 ug/L
Standard Deviation 56.5
|
275 ug/L
Standard Deviation 104
|
627 ug/L
Standard Deviation 328
|
453 ug/L
Standard Deviation 185
|
1131 ug/L
Standard Deviation 650
|
556 ug/L
Standard Deviation 194
|
1425 ug/L
Standard Deviation 555
|
1292 ug/L
Standard Deviation 572
|
982 ug/L
Standard Deviation 316
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-infusion and 20 minutes; 1, 2.25, 3.25, 4, 6, 8, 9, 12, and 24 hours plus one sampling at either 10 hour or 16 hour post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion dependent on dose regimen and enrollment positionPopulation: All participants that received at least 1 dose of study therapy and had evaluable data for endpoint. Results were pooled by dose taken and not by disease or regimen.
Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24h + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level. Blood samples for Tmax were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies.
Outcome measures
| Measure |
AL 10 mg QD 14-21
n=8 Participants
Participants received 10 mg MK-8628/OTX015 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 20 mg QD 14-21
n=6 Participants
Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 40 mg QD 14-21
n=8 Participants
Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 20 mg BID 21-21
n=3 Participants
Participants received 20 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
|
AL 80 mg QD 14-21
n=11 Participants
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 40 mg BID 14-21
n=13 Participants
Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.
|
AL 120 mg QD 14-21
n=31 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 120 mg QD 21-21
n=5 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
AL 160 mg QD 14-21
n=49 Participants
Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AML de Novo 80 mg QD 14-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AML/MDS 80 mg QD 14-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
OHM 10 mg QD 21-21
Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 20 mg QD 21-21
Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 40 mg QD 21-21
Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 80 mg QD 21-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 40 mg BID 21-21
Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
|
OHM 120 mg QD 21-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 120 mg QD 14-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
OHM 120 mg QD 5-7
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 5 of a 7-day cycle.
|
OHM 120 mg QD 7-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 7 of a 21-day cycle.
|
OHM/DLBCL 80 mg QD 14-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Concentration (Tmax) of MK-8628/OTX015
|
1.78 Hours
Standard Deviation 1.37
|
3.03 Hours
Standard Deviation 1.54
|
1.75 Hours
Standard Deviation 1.04
|
1.92 Hours
Standard Deviation 0.795
|
3.44 Hours
Standard Deviation 1.21
|
2.73 Hours
Standard Deviation 2.08
|
3.48 Hours
Standard Deviation 1.35
|
4.22 Hours
Standard Deviation 2.46
|
3.07 Hours
Standard Deviation 1.79
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-infusion and 20 minutes; 1, 2.25, 3.25, 4, 6, 8, 9, 12, and 24 hours plus one sampling at either 10 hour or 16 hour post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion dependent on dose regimen and enrollment positionPopulation: All participants that received at least 1 dose of study therapy and had evaluable data for endpoint. Results were pooled by dose taken and not by disease or regimen.
Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24h + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level. Blood samples for t1/2 were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies.
Outcome measures
| Measure |
AL 10 mg QD 14-21
n=8 Participants
Participants received 10 mg MK-8628/OTX015 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 20 mg QD 14-21
n=6 Participants
Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 40 mg QD 14-21
n=8 Participants
Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 20 mg BID 21-21
n=3 Participants
Participants received 20 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
|
AL 80 mg QD 14-21
n=11 Participants
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 40 mg BID 14-21
n=13 Participants
Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.
|
AL 120 mg QD 14-21
n=31 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 120 mg QD 21-21
n=5 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
AL 160 mg QD 14-21
n=49 Participants
Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AML de Novo 80 mg QD 14-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AML/MDS 80 mg QD 14-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
OHM 10 mg QD 21-21
Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 20 mg QD 21-21
Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 40 mg QD 21-21
Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 80 mg QD 21-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 40 mg BID 21-21
Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
|
OHM 120 mg QD 21-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 120 mg QD 14-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
OHM 120 mg QD 5-7
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 5 of a 7-day cycle.
|
OHM 120 mg QD 7-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 7 of a 21-day cycle.
|
OHM/DLBCL 80 mg QD 14-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Terminal Half-Life (t1/2) of MK-8628/OTX015
|
3.65 Hours
Standard Deviation 0.695
|
4.78 Hours
Standard Deviation 1.53
|
4.55 Hours
Standard Deviation 0.533
|
4.71 Hours
Standard Deviation 1.1
|
4.62 Hours
Standard Deviation 0.673
|
4.70 Hours
Standard Deviation 1.19
|
4.49 Hours
Standard Deviation 1.01
|
3.87 Hours
Standard Deviation 0.712
|
4.27 Hours
Standard Deviation 0.940
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-infusion and 20 minutes; 1, 2.25, 3.25, 4, 6, 8, 9, 12, and 24 hours plus one sampling at either 10 hour or 16 hour post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion dependent on dose regimen and enrollment positionPopulation: All participants that received at least 1 dose of study therapy and had evaluable data for endpoint. Results were pooled by dose taken and not by disease or regimen.
Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24h + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level. Blood samples for AUC 0-first were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies.
Outcome measures
| Measure |
AL 10 mg QD 14-21
n=8 Participants
Participants received 10 mg MK-8628/OTX015 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 20 mg QD 14-21
n=6 Participants
Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 40 mg QD 14-21
n=8 Participants
Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 20 mg BID 21-21
n=3 Participants
Participants received 20 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
|
AL 80 mg QD 14-21
n=11 Participants
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 40 mg BID 14-21
n=13 Participants
Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.
|
AL 120 mg QD 14-21
n=31 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 120 mg QD 21-21
n=5 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
AL 160 mg QD 14-21
n=49 Participants
Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AML de Novo 80 mg QD 14-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AML/MDS 80 mg QD 14-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
OHM 10 mg QD 21-21
Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 20 mg QD 21-21
Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 40 mg QD 21-21
Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 80 mg QD 21-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 40 mg BID 21-21
Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
|
OHM 120 mg QD 21-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 120 mg QD 14-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
OHM 120 mg QD 5-7
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 5 of a 7-day cycle.
|
OHM 120 mg QD 7-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 7 of a 21-day cycle.
|
OHM/DLBCL 80 mg QD 14-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration Time Curve of MK-8628/OTX015 From Time 0 to Infinity (AUC 0-inf)
|
1060 hr*ng/mL
Standard Deviation 191
|
2828 hr*ng/mL
Standard Deviation 983
|
5301 hr*ng/mL
Standard Deviation 924
|
3947 hr*ng/mL
Standard Deviation 1184
|
11910 hr*ng/mL
Standard Deviation 6987
|
5619 hr*ng/mL
Standard Deviation 1895
|
15240 hr*ng/mL
Standard Deviation 6021
|
13190 hr*ng/mL
Standard Deviation 3183
|
9833 hr*ng/mL
Standard Deviation 2968
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: cycle 1: Pre-infusion and 20 minutes; 1, 2.25, 3.25, 4, 6, 8, 9, 12, and 24 hours plus one sampling at either 10 hour or 16 hour post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion dependent on dose regimen and enrollment positionPopulation: All participants that received at least 1 dose of study therapy and had evaluable data for endpoint. Results were pooled by dose taken and not by disease or regimen.
Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24h + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level. Blood samples for CL/F were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies.
Outcome measures
| Measure |
AL 10 mg QD 14-21
n=8 Participants
Participants received 10 mg MK-8628/OTX015 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 20 mg QD 14-21
n=6 Participants
Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 40 mg QD 14-21
n=8 Participants
Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 20 mg BID 21-21
n=3 Participants
Participants received 20 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
|
AL 80 mg QD 14-21
n=11 Participants
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 40 mg BID 14-21
n=13 Participants
Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.
|
AL 120 mg QD 14-21
n=31 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 120 mg QD 21-21
n=5 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
AL 160 mg QD 14-21
n=49 Participants
Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AML de Novo 80 mg QD 14-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AML/MDS 80 mg QD 14-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
OHM 10 mg QD 21-21
Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 20 mg QD 21-21
Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 40 mg QD 21-21
Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 80 mg QD 21-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 40 mg BID 21-21
Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
|
OHM 120 mg QD 21-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 120 mg QD 14-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
OHM 120 mg QD 5-7
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 5 of a 7-day cycle.
|
OHM 120 mg QD 7-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 7 of a 21-day cycle.
|
OHM/DLBCL 80 mg QD 14-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Total Body Clearance (CL/F) of MK-8628/OTX015
|
9.71 L/hour
Standard Deviation 1.73
|
7.67 L/hour
Standard Deviation 2.13
|
7.76 L/hour
Standard Deviation 1.38
|
6.53 L/hour
Standard Deviation 1.88
|
7.91 L/hour
Standard Deviation 3.04
|
7.49 L/hour
Standard Deviation 2.18
|
8.61 L/hour
Standard Deviation 2.22
|
12.7 L/hour
Standard Deviation 2.80
|
8.87 L/hour
Standard Deviation 2.60
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-infusion and 20 minutes; 1, 2.25, 3.25, 4, 6, 8, 9, 12, and 24 hours plus one sampling at either 10 hour or 16 hour post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion dependent on dose regimen and enrollment positionPopulation: All participants that received at least 1 dose of study therapy and had evaluable data for endpoint. Results were pooled by dose taken and not by disease or regimen.
Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24h + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level. Blood samples for Vz/F were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies.
Outcome measures
| Measure |
AL 10 mg QD 14-21
n=8 Participants
Participants received 10 mg MK-8628/OTX015 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 20 mg QD 14-21
n=6 Participants
Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 40 mg QD 14-21
n=8 Participants
Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 20 mg BID 21-21
n=3 Participants
Participants received 20 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
|
AL 80 mg QD 14-21
n=11 Participants
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 40 mg BID 14-21
n=13 Participants
Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.
|
AL 120 mg QD 14-21
n=31 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 120 mg QD 21-21
n=5 Participants
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
AL 160 mg QD 14-21
n=49 Participants
Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AML de Novo 80 mg QD 14-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AML/MDS 80 mg QD 14-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
OHM 10 mg QD 21-21
Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 20 mg QD 21-21
Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 40 mg QD 21-21
Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 80 mg QD 21-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 40 mg BID 21-21
Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
|
OHM 120 mg QD 21-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 120 mg QD 14-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
OHM 120 mg QD 5-7
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 5 of a 7-day cycle.
|
OHM 120 mg QD 7-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 7 of a 21-day cycle.
|
OHM/DLBCL 80 mg QD 14-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Volume of Distribution at Steady State (Vz/F) of MK-8628/OTX015
|
49.6 Liters
Standard Deviation 1.0
|
49.1 Liters
Standard Deviation 3.51
|
50.8 Liters
Standard Deviation 10.0
|
42.4 Liters
Standard Deviation 4.25
|
50.4 Liters
Standard Deviation 17.5
|
48.2 Liters
Standard Deviation 9.22
|
54.2 Liters
Standard Deviation 14.4
|
69.3 Liters
Standard Deviation 13.3
|
52.0 Liters
Standard Deviation 9.18
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
AL 10 mg QD 14-21
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
AL 20 mg QD 14-21
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
AL 40 mg QD 14-21
Serious events: 3 serious events
Other events: 4 other events
Deaths: 4 deaths
AL 20 mg BID 21-21
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
AL 80 mg QD 14-21
Serious events: 3 serious events
Other events: 4 other events
Deaths: 4 deaths
AL 40 mg BID 14-21
Serious events: 7 serious events
Other events: 8 other events
Deaths: 7 deaths
AL 120 mg QD 14-21
Serious events: 6 serious events
Other events: 7 other events
Deaths: 7 deaths
AL 120 mg QD 21-21
Serious events: 5 serious events
Other events: 6 other events
Deaths: 6 deaths
AL 160 mg QD 14-21
Serious events: 4 serious events
Other events: 6 other events
Deaths: 6 deaths
AML de Novo 80 mg QD 14-21
Serious events: 14 serious events
Other events: 18 other events
Deaths: 15 deaths
AML/MDS 80 mg QD 14-21
Serious events: 14 serious events
Other events: 16 other events
Deaths: 15 deaths
OHM 10 mg QD 21-21
Serious events: 3 serious events
Other events: 5 other events
Deaths: 3 deaths
OHM 20 mg QD 21-21
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
OHM 40 mg QD 21-21
Serious events: 0 serious events
Other events: 4 other events
Deaths: 2 deaths
OHM 40 mg BID 21-21
Serious events: 5 serious events
Other events: 6 other events
Deaths: 4 deaths
OHM 120 mg QD 21-21
Serious events: 6 serious events
Other events: 7 other events
Deaths: 5 deaths
OHM 120 mg QD 14-21
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
OHM 120 mg QD 5-7
Serious events: 2 serious events
Other events: 5 other events
Deaths: 2 deaths
OHM 120 mg QD 7-21
Serious events: 2 serious events
Other events: 5 other events
Deaths: 5 deaths
OHM/DLBCL 80 mg QD 14-21
Serious events: 5 serious events
Other events: 15 other events
Deaths: 9 deaths
OHM 80 mg QD 21-21
Serious events: 4 serious events
Other events: 7 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
AL 10 mg QD 14-21
n=3 participants at risk
Participants received 10 mg MK-8628/OTX015 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 20 mg QD 14-21
n=3 participants at risk
Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 40 mg QD 14-21
n=4 participants at risk
Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 20 mg BID 21-21
n=3 participants at risk
Participants received 20 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
|
AL 80 mg QD 14-21
n=4 participants at risk
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 40 mg BID 14-21
n=8 participants at risk
Participants received 40 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.
|
AL 120 mg QD 14-21
n=7 participants at risk
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 120 mg QD 21-21
n=6 participants at risk
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
AL 160 mg QD 14-21
n=6 participants at risk
Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AML de Novo 80 mg QD 14-21
n=18 participants at risk
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AML/MDS 80 mg QD 14-21
n=16 participants at risk
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
OHM 10 mg QD 21-21
n=5 participants at risk
Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 20 mg QD 21-21
n=3 participants at risk
Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 40 mg QD 21-21
n=4 participants at risk
Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 40 mg BID 21-21
n=6 participants at risk
Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
|
OHM 120 mg QD 21-21
n=7 participants at risk
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 120 mg QD 14-21
n=3 participants at risk
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
OHM 120 mg QD 5-7
n=5 participants at risk
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 5 of a 7-day cycle.
|
OHM 120 mg QD 7-21
n=5 participants at risk
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 7 of a 21-day cycle.
|
OHM/DLBCL 80 mg QD 14-21
n=15 participants at risk
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
OHM 80 mg QD 21-21
n=7 participants at risk
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Anorectal disorder
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
2/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
11.1%
2/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
75.0%
3/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
2/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
2/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
22.2%
4/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
4/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Blood and lymphatic system disorders
Haemorrhagic disorder
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
37.5%
3/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
11.1%
2/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
83.3%
5/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
28.6%
2/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
28.6%
2/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
40.0%
2/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
11.1%
2/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
13.3%
2/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
General disorders
Disease progression
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
General disorders
General physical health deterioration
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
General disorders
Puncture site haemorrhage
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
2/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Aspergillosis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
3/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Cerebral aspergillosis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
2/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Enterobacter infection
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Eye infection
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Infectious peritonitis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Lung infection pseudomonal
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
42.9%
3/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
3/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
31.2%
5/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Septic shock
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Viral skin infection
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Investigations
Blood calcium increased
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Investigations
Enterococcus test positive
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Investigations
Factor VII deficiency
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Investigations
Hyperbilirubinaemia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
50.0%
3/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Investigations
Transaminases increased
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Nervous system disorders
Haemorrhage intracranial
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
2/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
2/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial haemorrhage
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
28.6%
2/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Vascular disorders
Air embolism
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
Other adverse events
| Measure |
AL 10 mg QD 14-21
n=3 participants at risk
Participants received 10 mg MK-8628/OTX015 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 20 mg QD 14-21
n=3 participants at risk
Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 40 mg QD 14-21
n=4 participants at risk
Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 20 mg BID 21-21
n=3 participants at risk
Participants received 20 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
|
AL 80 mg QD 14-21
n=4 participants at risk
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 40 mg BID 14-21
n=8 participants at risk
Participants received 40 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.
|
AL 120 mg QD 14-21
n=7 participants at risk
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AL 120 mg QD 21-21
n=6 participants at risk
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
AL 160 mg QD 14-21
n=6 participants at risk
Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AML de Novo 80 mg QD 14-21
n=18 participants at risk
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
AML/MDS 80 mg QD 14-21
n=16 participants at risk
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
OHM 10 mg QD 21-21
n=5 participants at risk
Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 20 mg QD 21-21
n=3 participants at risk
Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 40 mg QD 21-21
n=4 participants at risk
Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 40 mg BID 21-21
n=6 participants at risk
Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
|
OHM 120 mg QD 21-21
n=7 participants at risk
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
OHM 120 mg QD 14-21
n=3 participants at risk
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
OHM 120 mg QD 5-7
n=5 participants at risk
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 5 of a 7-day cycle.
|
OHM 120 mg QD 7-21
n=5 participants at risk
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 7 of a 21-day cycle.
|
OHM/DLBCL 80 mg QD 14-21
n=15 participants at risk
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
|
OHM 80 mg QD 21-21
n=7 participants at risk
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Conjunctivitis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
General disorders
Asthenia
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
100.0%
3/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
75.0%
3/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
66.7%
2/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
62.5%
5/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
57.1%
4/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
2/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
2/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
55.6%
10/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
62.5%
10/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
80.0%
4/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
75.0%
3/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
50.0%
3/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
71.4%
5/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
66.7%
2/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
40.0%
2/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
60.0%
3/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
5/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
42.9%
3/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
General disorders
Puncture site pain
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
50.0%
2/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Gingival disorder
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Gingival hypertrophy
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
2/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Melaena
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
4/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
50.0%
2/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
50.0%
4/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
28.6%
2/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
50.0%
3/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
50.0%
3/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
38.9%
7/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
68.8%
11/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
50.0%
3/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
28.6%
2/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
80.0%
4/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
80.0%
4/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
46.7%
7/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
42.9%
3/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
2/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
2/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
11.1%
2/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
2/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
3/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Tongue coated
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
2/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
3/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
18.8%
3/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
50.0%
2/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
50.0%
3/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
42.9%
3/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
40.0%
2/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
13.3%
2/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
General disorders
Cancer pain
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
General disorders
Catheter site related reaction
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
General disorders
Chills
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
General disorders
General physical health deterioration
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
General disorders
Facial pain
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
General disorders
Feeling cold
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
General disorders
Irritability
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
General disorders
Localised Oedema
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
General disorders
Malaise
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
General disorders
Oedema
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
66.7%
2/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
2/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
General disorders
Pain
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
11.1%
2/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
2/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
General disorders
Puncture site haemorrhage
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Blood and lymphatic system disorders
Anaemia
|
66.7%
2/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
66.7%
2/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
75.0%
3/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
100.0%
4/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
87.5%
7/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
71.4%
5/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
83.3%
5/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
50.0%
3/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
50.0%
9/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
43.8%
7/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
50.0%
3/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
60.0%
3/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
57.1%
4/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
66.7%
2/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
2/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
2/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
2/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Blood and lymphatic system disorders
Haemorrhagic disorder
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
2/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
28.6%
2/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
2/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
50.0%
2/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
28.6%
2/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
38.9%
7/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
4/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
40.0%
2/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
66.7%
2/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
66.7%
2/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
50.0%
2/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
75.0%
3/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
75.0%
6/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
28.6%
2/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
2/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
2/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
38.9%
7/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
18.8%
3/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
50.0%
2/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
42.9%
3/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
40.0%
2/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
26.7%
4/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
42.9%
3/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
2/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
18.8%
3/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Congenital, familial and genetic disorders
Factor V deficiency
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Eye disorders
Exophthalmos
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Eye disorders
Eye disorder
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Eye disorders
Photophobia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
2/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
50.0%
4/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
28.6%
2/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
22.2%
4/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
40.0%
2/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
28.6%
2/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
60.0%
3/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Breath odour
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Investigations
Transaminases increased
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
50.0%
2/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
2/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
27.8%
5/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
18.8%
3/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
42.9%
3/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
40.0%
2/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
100.0%
4/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
50.0%
4/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
57.1%
4/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
100.0%
6/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
66.7%
4/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
50.0%
9/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
68.8%
11/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
75.0%
3/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
66.7%
4/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
71.4%
5/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
66.7%
2/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
80.0%
4/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
60.0%
3/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
60.0%
9/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
85.7%
6/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
2/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
2/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
5/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
28.6%
2/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Duodenogastric reflux
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
50.0%
2/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
13.3%
2/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
General disorders
Puncture site reaction
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
37.5%
3/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
2/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
4/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
40.0%
2/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
2/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
42.9%
3/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
40.0%
2/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
26.7%
4/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
28.6%
2/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
General disorders
Sense of oppression
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
General disorders
Swelling
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
General disorders
Weight decreased
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
50.0%
2/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
2/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
57.1%
4/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
66.7%
4/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
50.0%
3/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
27.8%
5/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
2/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
28.6%
2/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
3/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
28.6%
2/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
General disorders
Weight increased
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
13.3%
2/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Hepatobiliary disorders
Cytolytic hepatitis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Aspergillosis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Candidiasis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Eye infection
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
11.1%
2/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Gingival infection
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
66.7%
2/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
2/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
2/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
3/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
2/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
40.0%
2/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Human herpesvirus 6 infection
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Infection reactivation
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Localized infection
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
2/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Lyme disease
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Paronychia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Periodontal infection
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Prostate infection
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Prostatitis escherichia coli
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Rhinotracheitis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
28.6%
2/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Tinea Cruris
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
13.3%
2/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
2/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Viral skin infection
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Infections and infestations
Vulvitis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Injury, poisoning and procedural complications
Eyelid injury
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Injury, poisoning and procedural complications
Transfusion related complication
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Investigations
Aspergillus test positive
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Investigations
Factor VII deficiency
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
2/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Investigations
Hyperbilirubinaemia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
3/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Investigations
International normalised ratio
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Investigations
International normalised ratio decreased
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
28.6%
2/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
2/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
28.6%
2/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Investigations
Prothrombin time shortened
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
2/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
66.7%
4/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
2/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
44.4%
8/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
56.2%
9/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
2/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
66.7%
2/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
40.0%
2/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
60.0%
3/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
3/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
28.6%
2/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
28.6%
2/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
37.5%
3/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
57.1%
4/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
50.0%
3/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
3/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
31.2%
5/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
60.0%
3/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
42.9%
3/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
66.7%
2/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
28.6%
2/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
2/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
2/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
28.6%
2/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
2/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
28.6%
2/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
40.0%
2/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Musculoskeletal and connective tissue disorders
Back disorder
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
4/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
66.7%
2/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Musculoskeletal and connective tissue disorders
Bone disorder
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
2/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
11.1%
2/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
3/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
28.6%
2/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
28.6%
2/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukoerythroblastosis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Nervous system disorders
Anaesthesia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
2/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
11.1%
2/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
2/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
11.1%
2/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
4/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
28.6%
2/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
60.0%
3/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
26.7%
4/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
11.1%
2/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
4/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
28.6%
2/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
3/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Nervous system disorders
Migraine
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
11.1%
2/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
13.3%
2/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
11.1%
2/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Nervous system disorders
Viith nerve paralysis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
50.0%
2/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
3/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
5/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
11.1%
2/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
2/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
2/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
2/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
2/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
11.1%
2/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Reproductive system and breast disorders
Nipple disorder
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
13.3%
2/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
50.0%
2/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
50.0%
4/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
66.7%
4/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
6/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
18.8%
3/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
40.0%
2/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
50.0%
3/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
28.6%
2/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
40.0%
2/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
28.6%
2/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
66.7%
2/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
75.0%
6/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
28.6%
2/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
44.4%
8/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
4/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
40.0%
2/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
40.0%
2/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
26.7%
4/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
50.0%
2/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
37.5%
3/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
50.0%
3/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
38.9%
7/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
31.2%
5/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
2/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
28.6%
2/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
11.1%
2/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
28.6%
2/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
2/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
2/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
11.1%
2/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Eccymosis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
2/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
18.8%
3/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Erythrosis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
3/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
26.7%
4/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
28.6%
2/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
2/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
4/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
11.1%
2/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
50.0%
2/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
13.3%
2/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
2/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
28.6%
2/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
27.8%
5/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
2/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
28.6%
2/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
13.3%
2/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.7%
1/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
2/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Vascular disorders
Haematoma
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
3/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
18.8%
3/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
25.0%
1/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
28.6%
2/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
13.3%
2/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
16.7%
1/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
6.2%
1/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
20.0%
1/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Vascular disorders
Pallor
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Vascular disorders
Phlebitis
|
33.3%
1/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
12.5%
1/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/8 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
5.6%
1/18 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/16 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/4 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/6 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/3 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/5 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
0.00%
0/15 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
14.3%
1/7 • Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
The safety population consisted of all participants who received at least one dose of study therapy.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor has the opportunity to review all proposed publications regarding this trial 60 days prior to submission for publication. In addition, if requested, the investigator will withhold publication an additional 90 days to allow for filing a patent application or taking such other measures to establish and preserve its proprietary rights. Publication of the results of the study shall be made only as part of a publication of the results obtained by all sites performing the protocol.
- Publication restrictions are in place
Restriction type: OTHER