Trial Outcomes & Findings for A Dose Escalation Study of Adavosertib (MK-1775) in Combination With Either Gemcitabine, Cisplatin, or Carboplatin in Adults With Advanced Solid Tumors (MK-1775-001) (NCT NCT00648648)
NCT ID: NCT00648648
Last Updated: 2023-09-21
Results Overview
DLTs were adverse events (AEs) considered at least possibly related to study drug that prevented escalation of the drug dose. Hematologic DLTs were any grade (Gr) 4-5 toxicity EXCEPT: Gr 4 anemia and Gr 4 leukopenia, Gr 4 neutropenia lasting for \<7 days, Gr 4 thrombocytopenia lasting for \<4 days except if a platelet transfusion is required, and Gr 3/Gr 4 neutropenia with fever \>38.5°C and/or infection requiring antibiotic or anti-fungal treatment. Non-hematologic DLT was defined as any Gr 3, 4, or 5 non-hematologic toxicity EXCEPT: nausea, vomiting, diarrhea, or dehydration (all Gr 3) occurring in a setting of inadequate compliance with supportive care measures and lasting for \<48 hours, alopecia of any grade, inadequately treated hypersensitivity reactions, and clinically non-significant, treatable or reversible lab abnormalities including liver function tests, uric acid, etc.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
206 participants
Primary outcome timeframe
Part 1: Up to 14 days, Part 2: Up to 28 days
Results posted on
2023-09-21
Participant Flow
206 participants were allocated to one of 28 treatment arms (3 Part 1 arms and 25 Part 2 arms). 8 participants from the Part 1 MK-1775 monotherapy arms continued into Part 2 of the study and received single dose (SD) combination treatment. For disposition purposes these participants are counted under Part 1 only.
Participant milestones
| Measure |
MK-1775 325 mg Single Dose
Participants received MK-1775 325 mg, orally, on Day 1.
|
MK-1775 650 mg Single Dose
Participants received MK-1775 650 mg, orally, on Day 1.
|
MK-1775 1300 mg Single Dose
Participants received MK-1775 1300 mg, orally, on Day 1.
|
MK-1775 100 mg Single Dose + Gemcitabine 1000 mg/m^2
Participants received gemcitabine 1000 mg/m\^2 as an intravenous (IV) infusion on Days 1, 8, and 15 in each 4-week cycle plus MK-1775 100 mg single dose, orally, on Day 2 of each cycle.
|
MK-1775 200 mg Single Dose + Gemcitabine 1000 mg/m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 in each 4-week cycle plus MK-1775 200 mg single dose, orally, on Day 2 of each cycle.
|
MK-1775 100 mg Single Dose + Cisplatin 75 mg/ m^2
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 200 mg Single Dose + Cisplatin 75 mg/ m^2
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 100 mg Single Dose + Carboplatin AUC 5
Participants received carboplatin at an area under the time curve concentration of 5 mg/min/ml (AUC5) as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 200 mg Single Dose + Carboplatin AUC 5
Participants received carboplatin AUC5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 325 mg Single Dose + Carboplatin AUC 5
Participants received carboplatin AUC5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 325 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 25 mg BID x2.5 Multi Dose + Gemcitabine 1000 mg/ m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4-week cycle plus MK-1775 25 mg orally twice daily (BID) for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 additional doses of MK-1775 25 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each cycle.
|
MK-1775 50/25 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 doses of MK-1775 25 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each 4 week cycle.
|
MK-1775 50 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion given once weekly for 3 consecutive weeks of a 4 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 additional doses of MK-1775 50 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each 4 week cycle.
|
MK-1775 100 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 100 mg orally once daily (QD) on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 125 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 125 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 150 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 150 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 175 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion given on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 175 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 200 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 200 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 50 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 100 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 125 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 125 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 150 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 150 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 200 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 250 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 250 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 75 mg BID x2.5 Multi Dose + Carboplatin AUC 5
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 75 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 150 mg BID x 2.5 Multi Dose + Carboplatin AUC 5
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 150 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 225 mg BID x2.5 Multi Dose + Carboplatin AUC 5
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 225 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 325 mg BID x2.5 Multi Dose + Carboplatin AUC 5
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 325 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
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Overall Study
STARTED
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3
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3
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3
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4
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9
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1
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10
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1
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10
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5
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7
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6
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10
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14
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4
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4
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4
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26
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12
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Overall Study
Treated
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3
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3
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3
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4
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8
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1
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9
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1
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3
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9
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6
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13
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6
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5
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4
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11
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16
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6
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4
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7
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6
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14
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4
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4
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4
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26
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12
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Overall Study
COMPLETED
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3
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3
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3
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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2
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Overall Study
NOT COMPLETED
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0
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0
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0
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4
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9
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1
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10
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1
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3
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10
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6
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13
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6
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5
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4
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11
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14
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6
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5
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7
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6
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10
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14
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4
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4
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4
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26
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12
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Dose Escalation Study of Adavosertib (MK-1775) in Combination With Either Gemcitabine, Cisplatin, or Carboplatin in Adults With Advanced Solid Tumors (MK-1775-001)
Baseline characteristics by cohort
| Measure |
MK-1775 325 mg Single Dose
n=3 Participants
Participants received MK-1775 325 mg, orally, on Day 1.
|
MK-1775 650 mg Single Dose
n=3 Participants
Participants received MK-1775 650 mg, orally, on Day 1.
|
MK-1775 1300 mg Single Dose
n=3 Participants
Participants received MK-1775 1300 mg, orally, on Day 1.
|
MK-1775 100 mg Single Dose + Gemcitabine 1000 mg/m^2
n=4 Participants
Participants received gemcitabine 1000 mg/m\^2 as an intravenous (IV) infusion on Days 1, 8, and 15 in each 4-week cycle plus MK-1775 100 mg single dose, orally, on Day 2 of each cycle.
|
MK-1775 200 mg Single Dose + Gemcitabine 1000 mg/m^2
n=9 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 in each 4-week cycle plus MK-1775 200 mg single dose, orally, on Day 2 of each cycle.
|
MK-1775 100 mg Single Dose + Cisplatin 75 mg/ m^2
n=1 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 200 mg Single Dose + Cisplatin 75 mg/ m^2
n=10 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 100 mg Single Dose + Carboplatin AUC 5
n=1 Participants
Participants received carboplatin at an area under the time curve concentration of 5 mg/min/ml (AUC5) as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 200 mg Single Dose + Carboplatin AUC 5
n=3 Participants
Participants received carboplatin AUC5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 325 mg Single Dose + Carboplatin AUC 5
n=10 Participants
Participants received carboplatin AUC5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 325 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 25 mg BID x2.5 Multi Dose + Gemcitabine 1000 mg/ m^2
n=6 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4-week cycle plus MK-1775 25 mg orally twice daily (BID) for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 additional doses of MK-1775 25 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each cycle.
|
MK-1775 50/25 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^2
n=13 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 doses of MK-1775 25 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each 4 week cycle.
|
MK-1775 50 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^2
n=6 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion given once weekly for 3 consecutive weeks of a 4 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 additional doses of MK-1775 50 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each 4 week cycle.
|
MK-1775 100 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2
n=5 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 100 mg orally once daily (QD) on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 125 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2
n=4 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 125 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 150 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2
n=11 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 150 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 175 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2
n=16 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion given on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 175 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 200 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2
n=6 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 200 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 50 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
n=5 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 100 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
n=7 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 125 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
n=6 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 125 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 150 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
n=10 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 150 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 200 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
n=14 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 250 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
n=4 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 250 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 75 mg BID x2.5 Multi Dose + Carboplatin AUC 5
n=4 Participants
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 75 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 150 mg BID x 2.5 Multi Dose + Carboplatin AUC 5
n=4 Participants
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 150 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 225 mg BID x2.5 Multi Dose + Carboplatin AUC 5
n=26 Participants
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 225 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 325 mg BID x2.5 Multi Dose + Carboplatin AUC 5
n=12 Participants
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 325 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
Total
n=206 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
64.0 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
44.0 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
67.7 years
STANDARD_DEVIATION 19.5 • n=5 Participants
|
47.0 years
STANDARD_DEVIATION 19.6 • n=4 Participants
|
60.6 years
STANDARD_DEVIATION 12.6 • n=21 Participants
|
58.0 years
STANDARD_DEVIATION 0 • n=8 Participants
|
61.5 years
STANDARD_DEVIATION 10.2 • n=8 Participants
|
75.0 years
STANDARD_DEVIATION 0 • n=24 Participants
|
64.7 years
STANDARD_DEVIATION 4.0 • n=42 Participants
|
55.6 years
STANDARD_DEVIATION 13.0 • n=42 Participants
|
56.2 years
STANDARD_DEVIATION 6.8 • n=42 Participants
|
55.1 years
STANDARD_DEVIATION 12.5 • n=42 Participants
|
64.5 years
STANDARD_DEVIATION 10.7 • n=36 Participants
|
49.8 years
STANDARD_DEVIATION 18.4 • n=36 Participants
|
60.5 years
STANDARD_DEVIATION 8.3 • n=24 Participants
|
64.7 years
STANDARD_DEVIATION 9.1 • n=135 Participants
|
64.8 years
STANDARD_DEVIATION 8.9 • n=136 Participants
|
57.8 years
STANDARD_DEVIATION 8.8 • n=44 Participants
|
55.2 years
STANDARD_DEVIATION 7.5 • n=667 Participants
|
56.1 years
STANDARD_DEVIATION 14.6 • n=125 Participants
|
48.8 years
STANDARD_DEVIATION 12.4 • n=117 Participants
|
51.5 years
STANDARD_DEVIATION 8.8 • n=1256 Participants
|
52.6 years
STANDARD_DEVIATION 9.4 • n=41 Participants
|
62.3 years
STANDARD_DEVIATION 3.3 • n=600 Participants
|
61.0 years
STANDARD_DEVIATION 9.6 • n=4 Participants
|
65.8 years
STANDARD_DEVIATION 8.8 • n=4 Participants
|
56.2 years
STANDARD_DEVIATION 12.8 • n=26 Participants
|
58.5 years
STANDARD_DEVIATION 12.6 • n=12 Participants
|
57.9 years
STANDARD_DEVIATION 11.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
5 Participants
n=135 Participants
|
11 Participants
n=136 Participants
|
3 Participants
n=44 Participants
|
3 Participants
n=667 Participants
|
2 Participants
n=125 Participants
|
3 Participants
n=117 Participants
|
5 Participants
n=1256 Participants
|
10 Participants
n=41 Participants
|
4 Participants
n=600 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
14 Participants
n=26 Participants
|
7 Participants
n=12 Participants
|
116 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
3 Participants
n=24 Participants
|
6 Participants
n=135 Participants
|
5 Participants
n=136 Participants
|
3 Participants
n=44 Participants
|
2 Participants
n=667 Participants
|
5 Participants
n=125 Participants
|
3 Participants
n=117 Participants
|
5 Participants
n=1256 Participants
|
4 Participants
n=41 Participants
|
0 Participants
n=600 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
12 Participants
n=26 Participants
|
5 Participants
n=12 Participants
|
90 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Part 1: Up to 14 days, Part 2: Up to 28 daysPopulation: All participants who received at least one dose of study treatment and were evaluable for DLT.
DLTs were adverse events (AEs) considered at least possibly related to study drug that prevented escalation of the drug dose. Hematologic DLTs were any grade (Gr) 4-5 toxicity EXCEPT: Gr 4 anemia and Gr 4 leukopenia, Gr 4 neutropenia lasting for \<7 days, Gr 4 thrombocytopenia lasting for \<4 days except if a platelet transfusion is required, and Gr 3/Gr 4 neutropenia with fever \>38.5°C and/or infection requiring antibiotic or anti-fungal treatment. Non-hematologic DLT was defined as any Gr 3, 4, or 5 non-hematologic toxicity EXCEPT: nausea, vomiting, diarrhea, or dehydration (all Gr 3) occurring in a setting of inadequate compliance with supportive care measures and lasting for \<48 hours, alopecia of any grade, inadequately treated hypersensitivity reactions, and clinically non-significant, treatable or reversible lab abnormalities including liver function tests, uric acid, etc.
Outcome measures
| Measure |
MK-1775 200 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2
n=6 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 200 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 50 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
n=4 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 100 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
n=7 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 125 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
n=6 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 125 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 150 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
n=10 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 150 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 200 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
n=14 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 250 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
n=4 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 250 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 75 mg BID x2.5 Multi Dose + Carboplatin AUC 5
n=4 Participants
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 75 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 150 mg BID x 2.5 Multi Dose + Carboplatin AUC 5
n=4 Participants
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 150 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 225 mg BID x2.5 Multi Dose + Carboplatin AUC 5
n=26 Participants
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 225 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 325 mg BID x2.5 Multi Dose + Carboplatin AUC 5
n=12 Participants
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 325 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 325 mg Single Dose
n=3 Participants
Participants received MK-1775 325 mg, orally, on Day 1.
|
MK-1775 650 mg Single Dose
n=3 Participants
Participants received MK-1775 650 mg, orally, on Day 1.
|
MK-1775 1300 mg Single Dose
n=3 Participants
Participants received MK-1775 1300 mg, orally, on Day 1.
|
MK-1775 100 mg Single Dose + Gemcitabine 1000 mg/m^2
n=6 Participants
Participants received gemcitabine 1000 mg/m\^2 as an intravenous (IV) infusion on Days 1, 8, and 15 in each 4-week cycle plus MK-1775 100 mg single dose, orally, on Day 2 of each cycle.
|
MK-1775 200 mg Single Dose + Gemcitabine 1000 mg/m^2
n=8 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 in each 4-week cycle plus MK-1775 200 mg single dose, orally, on Day 2 of each cycle.
|
MK-1775 100 mg Single Dose + Cisplatin 75 mg/ m^2
n=3 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 200 mg Single Dose + Cisplatin 75 mg/ m^2
n=10 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 100 mg Single Dose + Carboplatin AUC 5
n=3 Participants
Participants received carboplatin at an area under the time curve concentration of 5 mg/min/ml (AUC5) as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 200 mg Single Dose + Carboplatin AUC 5
n=4 Participants
Participants received carboplatin AUC5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 325 mg Single Dose + Carboplatin AUC 5
n=9 Participants
Participants received carboplatin AUC5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 325 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 25 mg BID x2.5 Multi Dose + Gemcitabine 1000 mg/ m^2
n=6 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4-week cycle plus MK-1775 25 mg orally twice daily (BID) for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 additional doses of MK-1775 25 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each cycle.
|
MK-1775 50/25 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^2
n=13 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 doses of MK-1775 25 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each 4 week cycle.
|
MK-1775 50 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^2
n=6 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion given once weekly for 3 consecutive weeks of a 4 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 additional doses of MK-1775 50 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each 4 week cycle.
|
MK-1775 100 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2
n=5 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 100 mg orally once daily (QD) on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 125 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2
n=4 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 125 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 150 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2
n=11 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 150 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 175 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2
n=16 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion given on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 175 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline, 8 hours after first MK-1775 dosePopulation: Participants in Parts 1, 2-A, and 2-B/3 with ≥1 dose treatment and evaluable CDC2 data at 8 hours post dosing. Per protocol the MK-1775 QD x2.5 Multi Dose + Gemcitabine groups, MK-1775 150, 200, and 250 mg BID x 2.5 Multi Dose + cisplatin 75 mg/m\^2 groups, and MK-1775 325 mg BID x 2.5 Multi Dose + carboplatin AUC 5 group did not have data reported
The pCDC2 level in skin cells was used as a marker to evaluate MK-1775 activity. Analysis was done by immunohistochemistry and the percentage of total CDC2-positive cells that were pCDC2 positive (% pCDC2-positive cells) at baseline and 8 hours after MK-1775 dosing were reported for participants in Part 1, 2-A, and 2-B/3 treatment groups with available data per protocol.
Outcome measures
| Measure |
MK-1775 200 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 200 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 50 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
n=3 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 100 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
n=7 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 125 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
n=1 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 125 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 150 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 150 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 200 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 250 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 250 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 75 mg BID x2.5 Multi Dose + Carboplatin AUC 5
n=4 Participants
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 75 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 150 mg BID x 2.5 Multi Dose + Carboplatin AUC 5
n=4 Participants
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 150 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 225 mg BID x2.5 Multi Dose + Carboplatin AUC 5
n=8 Participants
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 225 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 325 mg BID x2.5 Multi Dose + Carboplatin AUC 5
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 325 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 325 mg Single Dose
n=3 Participants
Participants received MK-1775 325 mg, orally, on Day 1.
|
MK-1775 650 mg Single Dose
n=3 Participants
Participants received MK-1775 650 mg, orally, on Day 1.
|
MK-1775 1300 mg Single Dose
n=3 Participants
Participants received MK-1775 1300 mg, orally, on Day 1.
|
MK-1775 100 mg Single Dose + Gemcitabine 1000 mg/m^2
n=4 Participants
Participants received gemcitabine 1000 mg/m\^2 as an intravenous (IV) infusion on Days 1, 8, and 15 in each 4-week cycle plus MK-1775 100 mg single dose, orally, on Day 2 of each cycle.
|
MK-1775 200 mg Single Dose + Gemcitabine 1000 mg/m^2
n=7 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 in each 4-week cycle plus MK-1775 200 mg single dose, orally, on Day 2 of each cycle.
|
MK-1775 100 mg Single Dose + Cisplatin 75 mg/ m^2
n=1 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 200 mg Single Dose + Cisplatin 75 mg/ m^2
n=9 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 100 mg Single Dose + Carboplatin AUC 5
n=1 Participants
Participants received carboplatin at an area under the time curve concentration of 5 mg/min/ml (AUC5) as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 200 mg Single Dose + Carboplatin AUC 5
n=3 Participants
Participants received carboplatin AUC5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 325 mg Single Dose + Carboplatin AUC 5
n=8 Participants
Participants received carboplatin AUC5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 325 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 25 mg BID x2.5 Multi Dose + Gemcitabine 1000 mg/ m^2
n=6 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4-week cycle plus MK-1775 25 mg orally twice daily (BID) for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 additional doses of MK-1775 25 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each cycle.
|
MK-1775 50/25 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^2
n=6 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 doses of MK-1775 25 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each 4 week cycle.
|
MK-1775 50 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^2
n=6 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion given once weekly for 3 consecutive weeks of a 4 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 additional doses of MK-1775 50 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each 4 week cycle.
|
MK-1775 100 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 100 mg orally once daily (QD) on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 125 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 125 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 150 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 150 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 175 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion given on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 175 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Total Cyclin-dependent Kinase (CDC2)-Positive Cells That Were Phosphorylated (pCDC2) in Skin Cells at Baseline and 8 Hours After MK-1775 Dosing
Percentage after dosing
|
—
|
17.8 percentage of cells
Interval 9.2 to 34.4
|
14.4 percentage of cells
Interval 9.3 to 22.1
|
19.9 percentage of cells
Interval 6.3 to 62.2
|
—
|
—
|
—
|
12.1 percentage of cells
Interval 6.9 to 21.5
|
16.8 percentage of cells
Interval 9.5 to 29.6
|
11.5 percentage of cells
Interval 7.7 to 17.2
|
—
|
18 percentage of cells
Interval 9.3 to 34.7
|
13.4 percentage of cells
Interval 6.9 to 25.8
|
20.6 percentage of cells
Interval 10.7 to 39.9
|
28.9 percentage of cells
Interval 16.3 to 51.2
|
35.7 percentage of cells
Interval 23.2 to 55.0
|
14.8 percentage of cells
Interval 4.7 to 46.4
|
22.1 percentage of cells
Interval 15.1 to 32.4
|
41.9 percentage of cells
Interval 13.4 to 131.3
|
20.9 percentage of cells
Interval 10.8 to 40.3
|
17.1 percentage of cells
Interval 11.4 to 25.6
|
20.1 percentage of cells
Interval 12.6 to 32.0
|
13.7 percentage of cells
Interval 8.6 to 21.8
|
16.6 percentage of cells
Interval 10.4 to 26.4
|
—
|
—
|
—
|
—
|
|
Percentage of Total Cyclin-dependent Kinase (CDC2)-Positive Cells That Were Phosphorylated (pCDC2) in Skin Cells at Baseline and 8 Hours After MK-1775 Dosing
Baseline percentage
|
—
|
16.4 percentage of cells
Interval 10.7 to 25.2
|
24.1 percentage of cells
Interval 18.2 to 31.9
|
21.4 percentage of cells
Interval 10.2 to 45.1
|
—
|
—
|
—
|
15.7 percentage of cells
Interval 10.9 to 22.8
|
27 percentage of cells
Interval 18.6 to 39.2
|
21 percentage of cells
Interval 15.9 to 27.8
|
—
|
40.8 percentage of cells
Interval 26.6 to 62.7
|
35.1 percentage of cells
Interval 22.8 to 54.0
|
36.2 percentage of cells
Interval 23.6 to 55.7
|
53.2 percentage of cells
Interval 36.7 to 77.2
|
40.7 percentage of cells
Interval 30.7 to 53.9
|
16.1 percentage of cells
Interval 7.6 to 33.8
|
28.6 percentage of cells
Interval 22.3 to 36.7
|
34.4 percentage of cells
Interval 16.3 to 72.4
|
17.6 percentage of cells
Interval 11.4 to 27.0
|
22.4 percentage of cells
Interval 17.0 to 29.6
|
28.1 percentage of cells
Interval 20.7 to 38.1
|
18.3 percentage of cells
Interval 13.5 to 24.8
|
30.8 percentage of cells
Interval 22.7 to 41.7
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 24 hours after first MK-1775 dosePopulation: All participants in the Part 2-B/3 MK-1775 QD x2 Multi Dose plus Gemcitabine treatment groups who received at least one dose of study treatment and had evaluable CDC2 data at 24 hours post dosing. Per protocol, the Part 1, Part 2-A, and Part 2-B/3 MK-1775 BID treatment groups did not have data reported for this time point.
The pCDC2 level in skin cells was used as a marker to evaluate MK-1775 activity. Analysis was done by immunohistochemistry and the percentage of total pCDC2 at baseline and 24 hours after MK-1775 dosing were reported for participants in the Part 2-B/3 MK-1775 QD x2 Multi Dose plus Gemcitabine treatment groups with available data per protocol.
Outcome measures
| Measure |
MK-1775 200 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2
n=4 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 200 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 50 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 100 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 125 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 125 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 150 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 150 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 200 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 250 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 250 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 75 mg BID x2.5 Multi Dose + Carboplatin AUC 5
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 75 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 150 mg BID x 2.5 Multi Dose + Carboplatin AUC 5
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 150 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 225 mg BID x2.5 Multi Dose + Carboplatin AUC 5
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 225 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 325 mg BID x2.5 Multi Dose + Carboplatin AUC 5
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 325 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 325 mg Single Dose
Participants received MK-1775 325 mg, orally, on Day 1.
|
MK-1775 650 mg Single Dose
Participants received MK-1775 650 mg, orally, on Day 1.
|
MK-1775 1300 mg Single Dose
Participants received MK-1775 1300 mg, orally, on Day 1.
|
MK-1775 100 mg Single Dose + Gemcitabine 1000 mg/m^2
Participants received gemcitabine 1000 mg/m\^2 as an intravenous (IV) infusion on Days 1, 8, and 15 in each 4-week cycle plus MK-1775 100 mg single dose, orally, on Day 2 of each cycle.
|
MK-1775 200 mg Single Dose + Gemcitabine 1000 mg/m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 in each 4-week cycle plus MK-1775 200 mg single dose, orally, on Day 2 of each cycle.
|
MK-1775 100 mg Single Dose + Cisplatin 75 mg/ m^2
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 200 mg Single Dose + Cisplatin 75 mg/ m^2
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 100 mg Single Dose + Carboplatin AUC 5
Participants received carboplatin at an area under the time curve concentration of 5 mg/min/ml (AUC5) as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 200 mg Single Dose + Carboplatin AUC 5
Participants received carboplatin AUC5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 325 mg Single Dose + Carboplatin AUC 5
Participants received carboplatin AUC5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 325 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 25 mg BID x2.5 Multi Dose + Gemcitabine 1000 mg/ m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4-week cycle plus MK-1775 25 mg orally twice daily (BID) for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 additional doses of MK-1775 25 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each cycle.
|
MK-1775 50/25 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 doses of MK-1775 25 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each 4 week cycle.
|
MK-1775 50 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion given once weekly for 3 consecutive weeks of a 4 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 additional doses of MK-1775 50 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each 4 week cycle.
|
MK-1775 100 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2
n=4 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 100 mg orally once daily (QD) on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 125 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2
n=4 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 125 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 150 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2
n=11 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 150 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 175 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion given on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 175 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Total pCDC2 in Skin Cells at Baseline and 24 Hours After MK-1775 Dosing
Percentage after dosing
|
6.3 percentage of cells
Interval 3.6 to 11.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
29.9 percentage of cells
Interval 17.3 to 51.9
|
17.7 percentage of cells
Interval 10.2 to 30.7
|
12.7 percentage of cells
Interval 9.1 to 17.7
|
—
|
|
Percentage of Total pCDC2 in Skin Cells at Baseline and 24 Hours After MK-1775 Dosing
Baseline percentage
|
11.6 percentage of cells
Interval 7.9 to 16.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
47.5 percentage of cells
Interval 32.6 to 69.2
|
27.9 percentage of cells
Interval 19.1 to 40.7
|
18.7 percentage of cells
Interval 14.9 to 23.5
|
—
|
PRIMARY outcome
Timeframe: Baseline, 48 hours after first MK-1775 dosePopulation: All participants in Part 2-B/3 MK-1775 (150 mg, 200 mg, 250) BID x 2.5 Multi Dose plus cisplatin 75 mg/m\^2 groups and 325 mg BID x2.5 Multi Dose + carboplatin group who received ≥1 dose of study treatment and had evaluable CDC2 data at 48 hours post dose. Per protocol, Part 1, Part 2-A, and remaining Part 2-B/3 groups did not have data reported.
The pCDC2 level in skin cells was used as a marker to evaluate MK-1775 activity. Analysis was done by immunohistochemistry and the percentage of total pCDC2 at baseline and at 48 hours after MK-1775 dosing were reported for participants in the Part 2-B/3 MK-1775 (150 mg, 200 mg, 250) BID x 2.5 Multi Dose plus cisplatin 75 mg/m\^2 groups and the 325 mg BID x2.5 Multi Dose + Carboplatin group with available data per protocol.
Outcome measures
| Measure |
MK-1775 200 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 200 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 50 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 100 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 125 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 125 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 150 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
n=8 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 150 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 200 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
n=9 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 250 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
n=4 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 250 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 75 mg BID x2.5 Multi Dose + Carboplatin AUC 5
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 75 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 150 mg BID x 2.5 Multi Dose + Carboplatin AUC 5
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 150 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 225 mg BID x2.5 Multi Dose + Carboplatin AUC 5
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 225 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 325 mg BID x2.5 Multi Dose + Carboplatin AUC 5
n=9 Participants
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 325 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 325 mg Single Dose
Participants received MK-1775 325 mg, orally, on Day 1.
|
MK-1775 650 mg Single Dose
Participants received MK-1775 650 mg, orally, on Day 1.
|
MK-1775 1300 mg Single Dose
Participants received MK-1775 1300 mg, orally, on Day 1.
|
MK-1775 100 mg Single Dose + Gemcitabine 1000 mg/m^2
Participants received gemcitabine 1000 mg/m\^2 as an intravenous (IV) infusion on Days 1, 8, and 15 in each 4-week cycle plus MK-1775 100 mg single dose, orally, on Day 2 of each cycle.
|
MK-1775 200 mg Single Dose + Gemcitabine 1000 mg/m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 in each 4-week cycle plus MK-1775 200 mg single dose, orally, on Day 2 of each cycle.
|
MK-1775 100 mg Single Dose + Cisplatin 75 mg/ m^2
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 200 mg Single Dose + Cisplatin 75 mg/ m^2
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 100 mg Single Dose + Carboplatin AUC 5
Participants received carboplatin at an area under the time curve concentration of 5 mg/min/ml (AUC5) as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 200 mg Single Dose + Carboplatin AUC 5
Participants received carboplatin AUC5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 325 mg Single Dose + Carboplatin AUC 5
Participants received carboplatin AUC5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 325 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 25 mg BID x2.5 Multi Dose + Gemcitabine 1000 mg/ m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4-week cycle plus MK-1775 25 mg orally twice daily (BID) for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 additional doses of MK-1775 25 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each cycle.
|
MK-1775 50/25 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 doses of MK-1775 25 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each 4 week cycle.
|
MK-1775 50 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion given once weekly for 3 consecutive weeks of a 4 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 additional doses of MK-1775 50 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each 4 week cycle.
|
MK-1775 100 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 100 mg orally once daily (QD) on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 125 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 125 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 150 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 150 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 175 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion given on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 175 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Total pCDC2 in Skin Cells at Baseline and 48 Hours After MK-1775 Dosing
Percentage after dosing
|
—
|
—
|
—
|
—
|
15.7 percentage of cells
Interval 10.0 to 24.8
|
7.4 percentage of cells
Interval 4.8 to 11.4
|
11.1 percentage of cells
Interval 5.9 to 21.1
|
—
|
—
|
—
|
15.1 percentage of cells
Interval 9.8 to 23.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Total pCDC2 in Skin Cells at Baseline and 48 Hours After MK-1775 Dosing
Baseline percentage
|
—
|
—
|
—
|
—
|
28.6 percentage of cells
Interval 23.6 to 34.6
|
31.5 percentage of cells
Interval 26.3 to 37.8
|
31.5 percentage of cells
Interval 24.0 to 41.3
|
—
|
—
|
—
|
33.5 percentage of cells
Interval 28.0 to 40.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 8 hours after MK-1775 dosePopulation: All treated participants with available C8hr data.
MK-1775 was measured in the plasma at 8 hours after dosing (Day 1 for single dose of monotherapy, Day 2 of single-dose combination therapy and QD x 2 Combination dosing, and Day 3 dose for BID X 2.5 combination dosing) for participants with available data.
Outcome measures
| Measure |
MK-1775 200 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2
n=6 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 200 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 50 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
n=4 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 100 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
n=7 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 125 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
n=5 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 125 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 150 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
n=7 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 150 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 200 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
n=10 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 250 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
n=3 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 250 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 75 mg BID x2.5 Multi Dose + Carboplatin AUC 5
n=4 Participants
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 75 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 150 mg BID x 2.5 Multi Dose + Carboplatin AUC 5
n=4 Participants
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 150 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 225 mg BID x2.5 Multi Dose + Carboplatin AUC 5
n=13 Participants
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 225 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 325 mg BID x2.5 Multi Dose + Carboplatin AUC 5
n=11 Participants
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 325 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 325 mg Single Dose
n=3 Participants
Participants received MK-1775 325 mg, orally, on Day 1.
|
MK-1775 650 mg Single Dose
n=3 Participants
Participants received MK-1775 650 mg, orally, on Day 1.
|
MK-1775 1300 mg Single Dose
n=3 Participants
Participants received MK-1775 1300 mg, orally, on Day 1.
|
MK-1775 100 mg Single Dose + Gemcitabine 1000 mg/m^2
n=6 Participants
Participants received gemcitabine 1000 mg/m\^2 as an intravenous (IV) infusion on Days 1, 8, and 15 in each 4-week cycle plus MK-1775 100 mg single dose, orally, on Day 2 of each cycle.
|
MK-1775 200 mg Single Dose + Gemcitabine 1000 mg/m^2
n=7 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 in each 4-week cycle plus MK-1775 200 mg single dose, orally, on Day 2 of each cycle.
|
MK-1775 100 mg Single Dose + Cisplatin 75 mg/ m^2
n=3 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 200 mg Single Dose + Cisplatin 75 mg/ m^2
n=8 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 100 mg Single Dose + Carboplatin AUC 5
n=2 Participants
Participants received carboplatin at an area under the time curve concentration of 5 mg/min/ml (AUC5) as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 200 mg Single Dose + Carboplatin AUC 5
n=4 Participants
Participants received carboplatin AUC5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 325 mg Single Dose + Carboplatin AUC 5
n=8 Participants
Participants received carboplatin AUC5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 325 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 25 mg BID x2.5 Multi Dose + Gemcitabine 1000 mg/ m^2
n=6 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4-week cycle plus MK-1775 25 mg orally twice daily (BID) for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 additional doses of MK-1775 25 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each cycle.
|
MK-1775 50/25 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^2
n=13 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 doses of MK-1775 25 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each 4 week cycle.
|
MK-1775 50 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^2
n=5 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion given once weekly for 3 consecutive weeks of a 4 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 additional doses of MK-1775 50 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each 4 week cycle.
|
MK-1775 100 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2
n=4 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 100 mg orally once daily (QD) on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 125 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2
n=3 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 125 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 150 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2
n=11 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 150 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 175 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2
n=11 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion given on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 175 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma Concentration of MK-1775 at 8 Hours After Administration (C8hr) of Single or Multiple Oral Doses
|
407 nM
Standard Deviation 183
|
113 nM
Standard Deviation 97.7
|
388 nM
Standard Deviation 149
|
748 nM
Standard Deviation 234
|
920 nM
Standard Deviation 439
|
1070 nM
Standard Deviation 528
|
2010 nM
Standard Deviation 581
|
184 nM
Standard Deviation 101
|
295 nM
Standard Deviation 161
|
985 nM
Standard Deviation 301
|
1960 nM
Standard Deviation 651
|
585 nM
Standard Deviation 262
|
1130 nM
Standard Deviation 73.2
|
2190 nM
Standard Deviation 791
|
129 nM
Standard Deviation 46.5
|
235 nM
Standard Deviation 136
|
108 nM
Standard Deviation 62.7
|
310 nM
Standard Deviation 168
|
119 nM
Standard Deviation 0.706
|
262 nM
Standard Deviation 52.1
|
425 nM
Standard Deviation 190
|
41.7 nM
Standard Deviation 16.3
|
65.4 nM
Standard Deviation 26.1
|
138 nM
Standard Deviation 38.8
|
188 nM
Standard Deviation 47.6
|
241 nM
Standard Deviation 92.3
|
355 nM
Standard Deviation 230
|
346 nM
Standard Deviation 144
|
PRIMARY outcome
Timeframe: At 0-4 hours, 4-8 hours, and 12-24 hours post Day 1 dose of monotherapyPopulation: All treated Part 1 participants with available urine sample data.
The mean cumulative amount of MK-1775 excreted unchanged in urine after a single oral dose was measured during the initial monotherapy cycle of the study. For this outcome measure, samples were collected and analyzed only for the MK-1775 monotherapy arms of the study at defined intervals after the Day 1 dose of monotherapy. Part 2 MK-1775 combination arms were not sampled per protocol.
Outcome measures
| Measure |
MK-1775 200 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 200 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 50 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 100 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 125 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 125 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 150 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 150 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 200 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 250 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 250 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 75 mg BID x2.5 Multi Dose + Carboplatin AUC 5
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 75 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 150 mg BID x 2.5 Multi Dose + Carboplatin AUC 5
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 150 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 225 mg BID x2.5 Multi Dose + Carboplatin AUC 5
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 225 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 325 mg BID x2.5 Multi Dose + Carboplatin AUC 5
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 325 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 325 mg Single Dose
n=1 Participants
Participants received MK-1775 325 mg, orally, on Day 1.
|
MK-1775 650 mg Single Dose
n=3 Participants
Participants received MK-1775 650 mg, orally, on Day 1.
|
MK-1775 1300 mg Single Dose
n=1 Participants
Participants received MK-1775 1300 mg, orally, on Day 1.
|
MK-1775 100 mg Single Dose + Gemcitabine 1000 mg/m^2
Participants received gemcitabine 1000 mg/m\^2 as an intravenous (IV) infusion on Days 1, 8, and 15 in each 4-week cycle plus MK-1775 100 mg single dose, orally, on Day 2 of each cycle.
|
MK-1775 200 mg Single Dose + Gemcitabine 1000 mg/m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 in each 4-week cycle plus MK-1775 200 mg single dose, orally, on Day 2 of each cycle.
|
MK-1775 100 mg Single Dose + Cisplatin 75 mg/ m^2
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 200 mg Single Dose + Cisplatin 75 mg/ m^2
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 100 mg Single Dose + Carboplatin AUC 5
Participants received carboplatin at an area under the time curve concentration of 5 mg/min/ml (AUC5) as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 200 mg Single Dose + Carboplatin AUC 5
Participants received carboplatin AUC5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 325 mg Single Dose + Carboplatin AUC 5
Participants received carboplatin AUC5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 325 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 25 mg BID x2.5 Multi Dose + Gemcitabine 1000 mg/ m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4-week cycle plus MK-1775 25 mg orally twice daily (BID) for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 additional doses of MK-1775 25 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each cycle.
|
MK-1775 50/25 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 doses of MK-1775 25 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each 4 week cycle.
|
MK-1775 50 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion given once weekly for 3 consecutive weeks of a 4 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 additional doses of MK-1775 50 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each 4 week cycle.
|
MK-1775 100 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 100 mg orally once daily (QD) on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 125 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 125 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 150 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 150 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 175 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion given on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 175 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Urine Excretion of MK-1775 24 Hours After the Day 1 Monotherapy Dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
16.7 mg
Standard Deviation NA
Standard Deviation not calculated since n=1
|
35.4 mg
Standard Deviation 9.86
|
154 mg
Standard Deviation NA
Standard Deviation not calculated since n=1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 up through discontinuation of study treatment (up to ~11.2 months)Population: All treated participants in Part 2 with measurable disease at baseline per RECIST criteria. Participants who were originally treated in Part 1 and continued in Part 2 were included in their respective Part 2 arms. Participants who could not be evaluated after treatment are categorized as "not evaluable (NE).
Best overall response achieved by a participant. Starting at Day 1, participants in Part 2 were evaluated for tumor response every 6-8 weeks until discontinuation from study treatment according to RECIST criteria; which are based on radiographic imaging. Recorded responses were either confirmed by Central Review or unconfirmed (Investigator assessment only), and included complete response (CR; defined as disappearance of all target lesions), partial response (PR; at least a 30% decrease in the sum of the longest diameter \[LD\] of target lesions, taking as reference the baseline sum LD), stable disease (SD; neither sufficient shrinkage to qualify for PR nor sufficient growth to qualify for PD, taking as reference the smallest sum LD since the treatment started), or progressive disease (PD; ≥20% increase in sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions).
Outcome measures
| Measure |
MK-1775 200 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2
n=5 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 200 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 50 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
n=3 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 100 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
n=5 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 125 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
n=5 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 125 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 150 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
n=10 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 150 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 200 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
n=11 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 250 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2
n=4 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 250 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 75 mg BID x2.5 Multi Dose + Carboplatin AUC 5
n=4 Participants
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 75 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 150 mg BID x 2.5 Multi Dose + Carboplatin AUC 5
n=4 Participants
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 150 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 225 mg BID x2.5 Multi Dose + Carboplatin AUC 5
n=24 Participants
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 225 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 325 mg BID x2.5 Multi Dose + Carboplatin AUC 5
n=12 Participants
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 325 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 325 mg Single Dose
Participants received MK-1775 325 mg, orally, on Day 1.
|
MK-1775 650 mg Single Dose
Participants received MK-1775 650 mg, orally, on Day 1.
|
MK-1775 1300 mg Single Dose
Participants received MK-1775 1300 mg, orally, on Day 1.
|
MK-1775 100 mg Single Dose + Gemcitabine 1000 mg/m^2
n=6 Participants
Participants received gemcitabine 1000 mg/m\^2 as an intravenous (IV) infusion on Days 1, 8, and 15 in each 4-week cycle plus MK-1775 100 mg single dose, orally, on Day 2 of each cycle.
|
MK-1775 200 mg Single Dose + Gemcitabine 1000 mg/m^2
n=6 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 in each 4-week cycle plus MK-1775 200 mg single dose, orally, on Day 2 of each cycle.
|
MK-1775 100 mg Single Dose + Cisplatin 75 mg/ m^2
n=3 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 200 mg Single Dose + Cisplatin 75 mg/ m^2
n=9 Participants
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 100 mg Single Dose + Carboplatin AUC 5
n=3 Participants
Participants received carboplatin at an area under the time curve concentration of 5 mg/min/ml (AUC5) as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 200 mg Single Dose + Carboplatin AUC 5
n=3 Participants
Participants received carboplatin AUC5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 325 mg Single Dose + Carboplatin AUC 5
n=9 Participants
Participants received carboplatin AUC5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 325 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 25 mg BID x2.5 Multi Dose + Gemcitabine 1000 mg/ m^2
n=5 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4-week cycle plus MK-1775 25 mg orally twice daily (BID) for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 additional doses of MK-1775 25 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each cycle.
|
MK-1775 50/25 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^2
n=9 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 doses of MK-1775 25 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each 4 week cycle.
|
MK-1775 50 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^2
n=5 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion given once weekly for 3 consecutive weeks of a 4 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 additional doses of MK-1775 50 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each 4 week cycle.
|
MK-1775 100 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2
n=4 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 100 mg orally once daily (QD) on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 125 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2
n=4 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 125 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 150 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2
n=10 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 150 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 175 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2
n=13 Participants
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion given on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 175 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Best Overall Response as Per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Confirmed PR
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Best Overall Response as Per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Unconfirmed PR
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Best Overall Response as Per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
CR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Response as Per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
PD
|
1 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
8 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Best Overall Response as Per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
NE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Response as Per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
SD
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
14 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
8 Participants
|
8 Participants
|
Adverse Events
MK-1775 325 mg Single Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MK-1775 650 mg Single Dose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MK-1775 1300 mg Single Dose
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MK-1775 100 mg Single Dose + Gemcitabine 1000 mg/m2
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
MK-1775 200 mg Single Dose + Gemcitabine 1000 mg/m2
Serious events: 3 serious events
Other events: 8 other events
Deaths: 1 deaths
MK-1775 100 mg Single Dose + Cisplatin 75 mg/m2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
MK-1775 200 mg Single Dose + Cisplatin 75 mg/m2
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
MK-1775 100 mg Single Dose + Carboplatin AUC 5
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
MK-1775 200 mg Single Dose + Carboplatin AUC 5
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
MK-1775 325 mg Single Dose + Carboplatin AUC 5
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
MK-1775 25 mg BID x2.5 Multi Dose + Gemcitabine 1000 mg/m2
Serious events: 3 serious events
Other events: 6 other events
Deaths: 1 deaths
MK-1775 50/25 mg BID x2.5 Multi Dose + Gemcitabine 1000 mg/m2
Serious events: 6 serious events
Other events: 13 other events
Deaths: 2 deaths
MK-1775 50 mg BID x2.5 Multi Dose + Gemcitabine 1000 mg/m2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
MK-1775 100 mg QD x2 Multi Dose + Gemcitabine 1000 mg/m2
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
MK-1775 125 mg QD x2 Multi Dose + Gemcitabine 1000 mg/m2
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
MK-1775 150 mg QD x2 Multi Dose + Gemcitabine 1000 mg/m2
Serious events: 4 serious events
Other events: 11 other events
Deaths: 0 deaths
MK-1775 175 mg QD x2 Multi Dose + Gemcitabine 1000 mg/m2
Serious events: 4 serious events
Other events: 16 other events
Deaths: 0 deaths
MK-1775 200 mg QD x2 Multi Dose + Gemcitabine 1000 mg/m2
Serious events: 5 serious events
Other events: 6 other events
Deaths: 1 deaths
MK-1775 50 mg BID x2.5 Multi Dose + Cisplatin 75 mg/m2
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
MK-1775 100 mg BID x2.5 Multi Dose + Cisplatin 75 mg/m2
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
MK-1775 125 mg BID x2.5 Multi Dose + Cisplatin 75 mg/m2
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
MK-1775 150 mg BID x2.5 Multi Dose + Cisplatin 75 mg/m2
Serious events: 5 serious events
Other events: 10 other events
Deaths: 0 deaths
MK-1775 200 mg BID x2.5 Multi Dose + Cisplatin 75 mg/m2
Serious events: 6 serious events
Other events: 13 other events
Deaths: 2 deaths
MK-1775 250 mg BID x2.5 Multi Dose + Cisplatin 75 mg/m2
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
MK-1775 75 mg BID x2.5 Multi Dose + Carboplatin AUC 5
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
MK-1775 150 mg BID x2.5 Multi Dose + Carboplatin AUC 5
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
MK-1775 225 mg BID x2.5 Multi Dose + Carboplatin AUC 5
Serious events: 13 serious events
Other events: 26 other events
Deaths: 0 deaths
MK-1775 325 mg BID x2.5 Multi Dose + Carboplatin AUC 5
Serious events: 7 serious events
Other events: 12 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
MK-1775 325 mg Single Dose
n=3 participants at risk
Participants received MK-1775 325 mg, orally, on Day 1.
|
MK-1775 650 mg Single Dose
n=3 participants at risk
Participants received MK-1775 650 mg, orally
|
MK-1775 1300 mg Single Dose
n=3 participants at risk
Participants received MK-1775 1300 mg, orally, on Day 1.
|
MK-1775 100 mg Single Dose + Gemcitabine 1000 mg/m2
n=6 participants at risk
Participants received gemcitabine 1000 mg/m\^2 as an intravenous (IV) infusion on Days 1, 8, and 15 in each 4-week cycle plus MK-1775 100 mg single dose, orally, on Day 2 of each cycle.
|
MK-1775 200 mg Single Dose + Gemcitabine 1000 mg/m2
n=8 participants at risk
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 in each 4-week cycle plus MK-1775 200 mg single dose, orally, on Day 2 of each cycle.
|
MK-1775 100 mg Single Dose + Cisplatin 75 mg/m2
n=3 participants at risk
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 200 mg Single Dose + Cisplatin 75 mg/m2
n=10 participants at risk
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 100 mg Single Dose + Carboplatin AUC 5
n=3 participants at risk
Participants received carboplatin at an area under the time curve concentration of 5 mg/min/ml (AUC5) as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 200 mg Single Dose + Carboplatin AUC 5
n=4 participants at risk
Participants received carboplatin AUC5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 325 mg Single Dose + Carboplatin AUC 5
n=9 participants at risk
Participants received carboplatin AUC5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 325 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 25 mg BID x2.5 Multi Dose + Gemcitabine 1000 mg/m2
n=6 participants at risk
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4-week cycle plus MK-1775 25 mg orally twice daily (BID) for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 additional doses of MK-1775 25 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each cycle.
|
MK-1775 50/25 mg BID x2.5 Multi Dose + Gemcitabine 1000 mg/m2
n=13 participants at risk
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 doses of MK-1775 25 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each 4 week cycle.
|
MK-1775 50 mg BID x2.5 Multi Dose + Gemcitabine 1000 mg/m2
n=6 participants at risk
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion given once weekly for 3 consecutive weeks of a 4 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 additional doses of MK-1775 50 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each 4 week cycle.
|
MK-1775 100 mg QD x2 Multi Dose + Gemcitabine 1000 mg/m2
n=5 participants at risk
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 100 mg orally once daily (QD) on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 125 mg QD x2 Multi Dose + Gemcitabine 1000 mg/m2
n=4 participants at risk
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 125 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 150 mg QD x2 Multi Dose + Gemcitabine 1000 mg/m2
n=11 participants at risk
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 150 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 175 mg QD x2 Multi Dose + Gemcitabine 1000 mg/m2
n=16 participants at risk
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion given on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 175 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 200 mg QD x2 Multi Dose + Gemcitabine 1000 mg/m2
n=6 participants at risk
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 200 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 50 mg BID x2.5 Multi Dose + Cisplatin 75 mg/m2
n=4 participants at risk
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 100 mg BID x2.5 Multi Dose + Cisplatin 75 mg/m2
n=7 participants at risk
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 125 mg BID x2.5 Multi Dose + Cisplatin 75 mg/m2
n=6 participants at risk
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 125 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 150 mg BID x2.5 Multi Dose + Cisplatin 75 mg/m2
n=10 participants at risk
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 150 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 200 mg BID x2.5 Multi Dose + Cisplatin 75 mg/m2
n=14 participants at risk
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 250 mg BID x2.5 Multi Dose + Cisplatin 75 mg/m2
n=4 participants at risk
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 250 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 75 mg BID x2.5 Multi Dose + Carboplatin AUC 5
n=4 participants at risk
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 75 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 150 mg BID x2.5 Multi Dose + Carboplatin AUC 5
n=4 participants at risk
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 150 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 225 mg BID x2.5 Multi Dose + Carboplatin AUC 5
n=26 participants at risk
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 225 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 325 mg BID x2.5 Multi Dose + Carboplatin AUC 5
n=12 participants at risk
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 325 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
2/26 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
2/26 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
2/16 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.5%
3/26 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
1/3 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
2/14 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
2/26 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
2/14 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
General disorders
Chest pain
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
General disorders
Pain
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
15.4%
2/13 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Recall phenomenon
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Investigations
Electrocardiogram ST-T segment elevation
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
2/14 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
Other adverse events
| Measure |
MK-1775 325 mg Single Dose
n=3 participants at risk
Participants received MK-1775 325 mg, orally, on Day 1.
|
MK-1775 650 mg Single Dose
n=3 participants at risk
Participants received MK-1775 650 mg, orally
|
MK-1775 1300 mg Single Dose
n=3 participants at risk
Participants received MK-1775 1300 mg, orally, on Day 1.
|
MK-1775 100 mg Single Dose + Gemcitabine 1000 mg/m2
n=6 participants at risk
Participants received gemcitabine 1000 mg/m\^2 as an intravenous (IV) infusion on Days 1, 8, and 15 in each 4-week cycle plus MK-1775 100 mg single dose, orally, on Day 2 of each cycle.
|
MK-1775 200 mg Single Dose + Gemcitabine 1000 mg/m2
n=8 participants at risk
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 in each 4-week cycle plus MK-1775 200 mg single dose, orally, on Day 2 of each cycle.
|
MK-1775 100 mg Single Dose + Cisplatin 75 mg/m2
n=3 participants at risk
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 200 mg Single Dose + Cisplatin 75 mg/m2
n=10 participants at risk
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 100 mg Single Dose + Carboplatin AUC 5
n=3 participants at risk
Participants received carboplatin at an area under the time curve concentration of 5 mg/min/ml (AUC5) as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 200 mg Single Dose + Carboplatin AUC 5
n=4 participants at risk
Participants received carboplatin AUC5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 325 mg Single Dose + Carboplatin AUC 5
n=9 participants at risk
Participants received carboplatin AUC5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 325 mg single dose orally, on Day 2 of each cycle.
|
MK-1775 25 mg BID x2.5 Multi Dose + Gemcitabine 1000 mg/m2
n=6 participants at risk
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4-week cycle plus MK-1775 25 mg orally twice daily (BID) for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 additional doses of MK-1775 25 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each cycle.
|
MK-1775 50/25 mg BID x2.5 Multi Dose + Gemcitabine 1000 mg/m2
n=13 participants at risk
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 doses of MK-1775 25 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each 4 week cycle.
|
MK-1775 50 mg BID x2.5 Multi Dose + Gemcitabine 1000 mg/m2
n=6 participants at risk
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion given once weekly for 3 consecutive weeks of a 4 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 additional doses of MK-1775 50 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each 4 week cycle.
|
MK-1775 100 mg QD x2 Multi Dose + Gemcitabine 1000 mg/m2
n=5 participants at risk
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 100 mg orally once daily (QD) on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 125 mg QD x2 Multi Dose + Gemcitabine 1000 mg/m2
n=4 participants at risk
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 125 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 150 mg QD x2 Multi Dose + Gemcitabine 1000 mg/m2
n=11 participants at risk
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 150 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 175 mg QD x2 Multi Dose + Gemcitabine 1000 mg/m2
n=16 participants at risk
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion given on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 175 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 200 mg QD x2 Multi Dose + Gemcitabine 1000 mg/m2
n=6 participants at risk
Participants received gemcitabine 1000 mg/m\^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus MK-1775 200 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
|
MK-1775 50 mg BID x2.5 Multi Dose + Cisplatin 75 mg/m2
n=4 participants at risk
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 50 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 100 mg BID x2.5 Multi Dose + Cisplatin 75 mg/m2
n=7 participants at risk
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 100 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 125 mg BID x2.5 Multi Dose + Cisplatin 75 mg/m2
n=6 participants at risk
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 125 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 150 mg BID x2.5 Multi Dose + Cisplatin 75 mg/m2
n=10 participants at risk
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 150 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 200 mg BID x2.5 Multi Dose + Cisplatin 75 mg/m2
n=14 participants at risk
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 200 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 250 mg BID x2.5 Multi Dose + Cisplatin 75 mg/m2
n=4 participants at risk
Participants received cisplatin 75 mg/ m\^2 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 250 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 75 mg BID x2.5 Multi Dose + Carboplatin AUC 5
n=4 participants at risk
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 75 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 150 mg BID x2.5 Multi Dose + Carboplatin AUC 5
n=4 participants at risk
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 150 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 225 mg BID x2.5 Multi Dose + Carboplatin AUC 5
n=26 participants at risk
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 225 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
MK-1775 325 mg BID x2.5 Multi Dose + Carboplatin AUC 5
n=12 participants at risk
Participants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus MK-1775 325 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
66.7%
2/3 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
2/8 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
5/10 • Number of events 8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
3/9 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
38.5%
5/13 • Number of events 6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
83.3%
5/6 • Number of events 8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
40.0%
2/5 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
45.5%
5/11 • Number of events 7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
31.2%
5/16 • Number of events 7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
66.7%
4/6 • Number of events 8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
42.9%
3/7 • Number of events 13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
60.0%
6/10 • Number of events 12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
42.9%
6/14 • Number of events 14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
75.0%
3/4 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
2/4 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
75.0%
3/4 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
69.2%
18/26 • Number of events 47 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
91.7%
11/12 • Number of events 20 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
2/12 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
3/6 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
66.7%
2/3 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
2/10 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
3/9 • Number of events 6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
46.2%
6/13 • Number of events 6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
40.0%
2/5 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
75.0%
3/4 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
18.2%
2/11 • Number of events 10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
37.5%
6/16 • Number of events 10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
3/6 • Number of events 8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
75.0%
3/4 • Number of events 6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
42.9%
3/7 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
80.0%
8/10 • Number of events 14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
7/14 • Number of events 10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
13/26 • Number of events 24 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
3/12 • Number of events 6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
2/10 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
22.2%
2/9 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
15.4%
2/13 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
1/7 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
21.4%
3/14 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
2/4 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
15.4%
4/26 • Number of events 6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
4/12 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
37.5%
3/8 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
38.5%
5/13 • Number of events 6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
27.3%
3/11 • Number of events 15 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
2/16 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
28.6%
2/7 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
2/10 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
21.4%
3/14 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
15.4%
4/26 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
2/12 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
1/7 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
2/26 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
3/12 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
28.6%
2/7 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
2/14 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
19.2%
5/26 • Number of events 10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
2/12 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
30.0%
3/10 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
66.7%
4/6 • Number of events 7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
62.5%
5/8 • Number of events 13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
1/3 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
80.0%
8/10 • Number of events 14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
55.6%
5/9 • Number of events 11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
66.7%
4/6 • Number of events 14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
53.8%
7/13 • Number of events 14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
66.7%
4/6 • Number of events 5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
80.0%
4/5 • Number of events 8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
100.0%
4/4 • Number of events 6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
81.8%
9/11 • Number of events 15 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
56.2%
9/16 • Number of events 15 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
66.7%
4/6 • Number of events 11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
100.0%
4/4 • Number of events 9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
85.7%
6/7 • Number of events 13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
100.0%
6/6 • Number of events 10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
100.0%
10/10 • Number of events 25 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
85.7%
12/14 • Number of events 46 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
100.0%
4/4 • Number of events 8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
75.0%
3/4 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
75.0%
3/4 • Number of events 11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
65.4%
17/26 • Number of events 38 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
66.7%
8/12 • Number of events 20 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
28.6%
2/7 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Oral pruritus
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Post-tussive vomiting
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Periorbital haemorrhage
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.5%
3/26 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Investigations
Alanine aminotransferase decreased
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
2/8 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
3/6 • Number of events 10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
60.0%
3/5 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
2/4 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
3/6 • Number of events 5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
28.6%
4/14 • Number of events 8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Investigations
Aspartate aminotransferase decreased
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
30.0%
3/10 • Number of events 5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
18.2%
2/11 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
2/10 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
28.6%
4/14 • Number of events 12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
2/4 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
2/8 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
3/6 • Number of events 7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
2/4 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
21.4%
3/14 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
2/26 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
2/26 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
18.2%
2/11 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
2/8 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
27.3%
3/11 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
37.5%
6/16 • Number of events 6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
3/6 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
2/12 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
2/26 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Plantar erythema
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
27.3%
3/11 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
23.1%
3/13 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
2/4 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
27.3%
3/11 • Number of events 6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
31.2%
5/16 • Number of events 6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.5%
3/26 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
15.4%
2/13 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
33.3%
1/3 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
4/8 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
30.0%
3/10 • Number of events 5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
44.4%
4/9 • Number of events 6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
66.7%
4/6 • Number of events 11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
69.2%
9/13 • Number of events 15 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
72.7%
8/11 • Number of events 18 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
18.8%
3/16 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
40.0%
4/10 • Number of events 5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
21.4%
3/14 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
2/4 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
13/26 • Number of events 25 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
41.7%
5/12 • Number of events 18 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
4/8 • Number of events 5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
22.2%
2/9 • Number of events 5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
23.1%
3/13 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
27.3%
3/11 • Number of events 6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
2/16 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
75.0%
3/4 • Number of events 5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.5%
3/26 • Number of events 9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
3/12 • Number of events 8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
37.5%
3/8 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
30.0%
3/10 • Number of events 6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
22.2%
2/9 • Number of events 7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
66.7%
4/6 • Number of events 18 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
63.6%
7/11 • Number of events 21 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
62.5%
10/16 • Number of events 20 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
66.7%
4/6 • Number of events 6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
42.9%
3/7 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
40.0%
4/10 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
28.6%
4/14 • Number of events 10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
38.5%
10/26 • Number of events 14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
41.7%
5/12 • Number of events 14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
2/12 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
37.5%
3/8 • Number of events 5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
55.6%
5/9 • Number of events 12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
3/6 • Number of events 8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
61.5%
8/13 • Number of events 16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
66.7%
4/6 • Number of events 14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
40.0%
2/5 • Number of events 7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
75.0%
3/4 • Number of events 13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
72.7%
8/11 • Number of events 34 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
56.2%
9/16 • Number of events 21 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
66.7%
4/6 • Number of events 7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
1/7 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
30.0%
3/10 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
35.7%
5/14 • Number of events 18 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
100.0%
4/4 • Number of events 12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
73.1%
19/26 • Number of events 53 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
6/12 • Number of events 25 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
18.2%
2/11 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Ear and labyrinth disorders
Deafness bilateral
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
1/7 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Ear and labyrinth disorders
External ear pain
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
1/7 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
66.7%
2/3 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
28.6%
2/7 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
3/6 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
30.0%
3/10 • Number of events 5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
2/14 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Eye disorders
Cataract
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Eye disorders
Deposit eye
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Eye disorders
Diplopia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Eye disorders
Eye discharge
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Eye disorders
Eye swelling
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
27.3%
3/11 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Eye disorders
Ophthalmoplegia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Eye disorders
Photophobia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Eye disorders
Photopsia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Eye disorders
Scleral haemorrhage
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
1/7 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Eye disorders
Visual impairment
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
2/10 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
1/7 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
2/10 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
2/14 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
3/12 • Number of events 5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
3/9 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
23.1%
3/13 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
2/4 • Number of events 5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
31.2%
5/16 • Number of events 7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
2/4 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
30.0%
3/10 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
21.4%
3/14 • Number of events 6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
4/12 • Number of events 6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
1/7 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
30.0%
3/10 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Anal inflammation
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
1/7 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
2/8 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
27.3%
3/11 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
2/16 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
2/14 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
15.4%
4/26 • Number of events 6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
3/12 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
4/8 • Number of events 10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
5/10 • Number of events 9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
22.2%
2/9 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
23.1%
3/13 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
40.0%
2/5 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
2/4 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
27.3%
3/11 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
4/16 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
66.7%
4/6 • Number of events 8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
2/4 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
71.4%
5/7 • Number of events 9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
60.0%
6/10 • Number of events 15 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
57.1%
8/14 • Number of events 13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
75.0%
3/4 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
75.0%
3/4 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
75.0%
3/4 • Number of events 5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
42.3%
11/26 • Number of events 15 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
58.3%
7/12 • Number of events 14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
2/10 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
General disorders
Axillary pain
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
General disorders
Catheter site pain
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
General disorders
Chest pain
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
1/7 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
General disorders
Chills
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
1/8 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
15.4%
2/13 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
28.6%
4/14 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
2/26 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
General disorders
Face oedema
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
83.3%
5/6 • Number of events 12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
62.5%
5/8 • Number of events 7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
66.7%
2/3 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
60.0%
6/10 • Number of events 13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
66.7%
2/3 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
44.4%
4/9 • Number of events 7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
100.0%
6/6 • Number of events 18 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
46.2%
6/13 • Number of events 10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
66.7%
4/6 • Number of events 11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
60.0%
3/5 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
75.0%
3/4 • Number of events 6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
54.5%
6/11 • Number of events 20 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
62.5%
10/16 • Number of events 15 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
83.3%
5/6 • Number of events 14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
75.0%
3/4 • Number of events 7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
71.4%
5/7 • Number of events 9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
3/6 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
80.0%
8/10 • Number of events 11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
57.1%
8/14 • Number of events 29 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
75.0%
3/4 • Number of events 5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
2/4 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
75.0%
3/4 • Number of events 6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
69.2%
18/26 • Number of events 40 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
58.3%
7/12 • Number of events 15 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
General disorders
Feeling cold
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
General disorders
Hernia pain
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
23.1%
3/13 • Number of events 5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
60.0%
3/5 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
2/16 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
2/26 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
General disorders
Local swelling
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
General disorders
Localised oedema
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
General disorders
Malaise
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
37.5%
3/8 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
30.8%
4/13 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
18.8%
3/16 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
2/4 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
15.4%
4/26 • Number of events 5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
41.7%
5/12 • Number of events 6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
15.4%
2/13 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
1/7 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
2/10 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
46.2%
6/13 • Number of events 6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
3/6 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
18.2%
2/11 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
2/16 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
2/10 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
2/4 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
General disorders
Pain
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
1/7 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
3/6 • Number of events 7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
37.5%
3/8 • Number of events 5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
66.7%
2/3 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
1/3 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
23.1%
3/13 • Number of events 10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
83.3%
5/6 • Number of events 14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
75.0%
3/4 • Number of events 5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
45.5%
5/11 • Number of events 9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
4/16 • Number of events 10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
66.7%
4/6 • Number of events 9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
1/7 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
66.7%
4/6 • Number of events 5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
2/10 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
2/14 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
30.8%
8/26 • Number of events 11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
2/12 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
2/8 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.5%
3/26 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
27.3%
3/11 • Number of events 8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
1/7 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
18.2%
2/11 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
2/4 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
2/26 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
2/16 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
18.2%
2/11 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
2/14 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
1/7 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Investigations
Blood urea increased
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Investigations
Body temperature increased
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
23.1%
3/13 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
1/7 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
2/14 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
75.0%
3/4 • Number of events 7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
2/10 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
3/6 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
30.8%
4/13 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
3/6 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
2/4 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
27.3%
3/11 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
18.8%
3/16 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
3/6 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
2/4 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
42.9%
3/7 • Number of events 5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
2/10 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
21.4%
3/14 • Number of events 5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
23.1%
6/26 • Number of events 7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
2/10 • Number of events 5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
22.2%
2/9 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
1/7 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
2/10 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
2/4 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
2/12 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperalbuminaemia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
23.1%
3/13 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
2/10 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
2/4 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
23.1%
3/13 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
2/4 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
2/26 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
75.0%
3/4 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
30.0%
3/10 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
23.1%
3/13 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
75.0%
3/4 • Number of events 5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
15.4%
4/26 • Number of events 5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
2/10 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
22.2%
2/9 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
15.4%
2/13 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
2/16 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
40.0%
4/10 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
2/14 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
75.0%
3/4 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
2/26 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
2/12 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
15.4%
2/13 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
2/16 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
2/4 • Number of events 5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
2/12 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
3/9 • Number of events 5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
2/10 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
22.2%
2/9 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
2/26 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
3/6 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
40.0%
2/5 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
18.8%
3/16 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
1/7 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
21.4%
3/14 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
2/4 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
2/26 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
3/12 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Finger deformity
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
2/10 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
22.2%
2/9 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
42.9%
3/7 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
23.1%
3/13 • Number of events 5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
2/16 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.5%
3/26 • Number of events 7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
2/10 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
23.1%
3/13 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
2/26 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
1/7 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Nervous system disorders
Asterixis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Nervous system disorders
Horner's syndrome
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
60.0%
3/5 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
2/16 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
1/7 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
2/10 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
2/4 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
23.1%
6/26 • Number of events 7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
4/12 • Number of events 5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
1/7 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
1/3 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
2/26 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
18.2%
2/11 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Psychiatric disorders
Delusion
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
40.0%
2/5 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
1/7 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
2/10 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
2/10 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Reproductive system and breast disorders
Scrotal swelling
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
2/8 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
15.4%
2/13 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
18.2%
2/11 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
1/7 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
2/10 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
21.4%
3/14 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
19.2%
5/26 • Number of events 6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
4/12 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmalgia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
15.4%
2/13 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
18.2%
2/11 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
2/26 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
23.1%
3/13 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
40.0%
2/5 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
100.0%
4/4 • Number of events 6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
3/6 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
2/4 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
28.6%
2/7 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
30.0%
3/10 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
2/14 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
2/4 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
50.0%
2/4 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.5%
3/26 • Number of events 3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
3/12 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.5%
3/26 • Number of events 5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
25.0%
1/4 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
14.3%
1/7 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
20.0%
1/5 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
2/12 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Vascular disorders
Haematoma
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
21.4%
3/14 • Number of events 4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Vascular disorders
Intra-abdominal haematoma
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
8.3%
1/12 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.7%
1/13 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
7.1%
1/14 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/8 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/3 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/5 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/11 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/16 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/6 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/7 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/10 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/14 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/4 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/26 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
0.00%
0/12 • Up to 30 days after the last dose of study drug (up to ~11.7 months)
All participants receiving at least one dose of study medication.
|
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 must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER