Trial Outcomes & Findings for A Combination Therapy Study of MK-2206 and AZD6244 in Participants With Advanced Solid Tumors (MK-2206-010) (NCT NCT01021748)
NCT ID: NCT01021748
Last Updated: 2018-08-07
Results Overview
Adverse events (AEs) were graded using Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. DLTs included: Grade 4 neutropenia lasting for ≥7 days; Grade 3 or Grade 4 neutropenia with fever \>38.5ºC and/or infection requiring antibiotic or anti-fungal treatment; Grade 4 thrombocytopenia (≤25.0 x 10\^9/L); Grade ≥3 non-hematologic toxicity with exceptions; Any drug-related AE, regardless of CTCAE Grade, leading to a dose modification of MK-2206 or AZD6244; Unresolved CTCAE Grade ≥3 drug-related toxicity requiring drug interruption for \>14 days; ≥ Grade 3 signs or symptoms of glucose intolerance and accompanied by ≥ Grade 2 hyperglycemia (glucose \>160 dL or 8.9 mmol/L); ≥ Grade 3 electrolyte abnormalities due to glucose intolerance and not attributable to another cause; Diagnosis of lactoacidosis or ketoacidosis; Persistent increases in corrected QT (QTc) interval (\>60 msec from baseline and/or \>500 msec); Clinically significant bradycardia.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
63 participants
Primary outcome timeframe
Cycle 1 (Up to 28 days)
Results posted on
2018-08-07
Participant Flow
Participant milestones
| Measure |
MK-2206 45 mg QOD + AZD6244 75 mg QD
Participants received MK-2206 45 mg oral tablets once every other day (QOD) PLUS AZD6244 75 mg oral capsules once daily (QD) starting on Day 1 of each 28-day cycle.
|
MK-2206 45 mg QOD + AZD6244 75 mg BID
Participants received MK-2206 45 mg oral tablets QOD PLUS AZD6244 75 mg oral capsules twice daily (BID) starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 50 mg BID
Participants received MK-2206 90 mg oral tablets once weekly (QW) PLUS AZD6244 50 mg oral capsules BID starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 75 mg QD
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 75 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 75 mg BID
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 75 mg oral capsules BID starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 100 mg QD
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 150 mg QD
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 150 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 100 mg QW + AZD6244 100 mg QD
Participants received MK-2206 100 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 135 mg QW + AZD6244 100 mg QD
Participants received MK-2206 135 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
7
|
7
|
9
|
3
|
3
|
6
|
17
|
|
Overall Study
Treated
|
6
|
4
|
7
|
7
|
9
|
3
|
3
|
6
|
17
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
7
|
7
|
9
|
3
|
3
|
6
|
16
|
Reasons for withdrawal
| Measure |
MK-2206 45 mg QOD + AZD6244 75 mg QD
Participants received MK-2206 45 mg oral tablets once every other day (QOD) PLUS AZD6244 75 mg oral capsules once daily (QD) starting on Day 1 of each 28-day cycle.
|
MK-2206 45 mg QOD + AZD6244 75 mg BID
Participants received MK-2206 45 mg oral tablets QOD PLUS AZD6244 75 mg oral capsules twice daily (BID) starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 50 mg BID
Participants received MK-2206 90 mg oral tablets once weekly (QW) PLUS AZD6244 50 mg oral capsules BID starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 75 mg QD
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 75 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 75 mg BID
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 75 mg oral capsules BID starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 100 mg QD
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 150 mg QD
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 150 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 100 mg QW + AZD6244 100 mg QD
Participants received MK-2206 100 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 135 mg QW + AZD6244 100 mg QD
Participants received MK-2206 135 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
2
|
0
|
2
|
0
|
1
|
0
|
7
|
|
Overall Study
Physician Decision
|
1
|
0
|
1
|
1
|
0
|
0
|
1
|
1
|
2
|
|
Overall Study
Progressive Disease
|
3
|
3
|
4
|
6
|
7
|
3
|
0
|
5
|
6
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Not Treated
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Combination Therapy Study of MK-2206 and AZD6244 in Participants With Advanced Solid Tumors (MK-2206-010)
Baseline characteristics by cohort
| Measure |
MK-2206 45 mg QOD + AZD6244 75 mg QD
n=6 Participants
Participants received MK-2206 45 mg oral tablets QOD PLUS AZD6244 75 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 45 mg QOD + AZD6244 75 mg BID
n=4 Participants
Participants received MK-2206 45 mg oral tablets QOD PLUS AZD6244 75 mg oral capsules BID starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 50 mg BID
n=7 Participants
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 50 mg oral capsules BID starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 75 mg QD
n=7 Participants
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 75 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 75 mg BID
n=9 Participants
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 75 mg oral capsules BID starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 100 mg QD
n=3 Participants
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 150 mg QD
n=3 Participants
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 150 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 100 mg QW + AZD6244 100 mg QD
n=6 Participants
Participants received MK-2206 100 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 135 mg QW + AZD6244 100 mg QD
n=17 Participants
Participants received MK-2206 135 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
55.0 Years
STANDARD_DEVIATION 8.0 • n=99 Participants
|
50.0 Years
STANDARD_DEVIATION 5.9 • n=107 Participants
|
48.9 Years
STANDARD_DEVIATION 8.6 • n=206 Participants
|
56.6 Years
STANDARD_DEVIATION 7.3 • n=7 Participants
|
56.1 Years
STANDARD_DEVIATION 12.5 • n=31 Participants
|
44.3 Years
STANDARD_DEVIATION 8.0 • n=30 Participants
|
63.0 Years
STANDARD_DEVIATION 6.2 • n=3 Participants
|
54.3 Years
STANDARD_DEVIATION 15.3 • n=6 Participants
|
64.7 Years
STANDARD_DEVIATION 9.4 • n=114 Participants
|
56.8 Years
STANDARD_DEVIATION 11.1
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
12 Participants
n=114 Participants
|
36 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=114 Participants
|
26 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (Up to 28 days)Population: The population consisted of all participants who completed ≥ 80% of the first cycle of combination therapy unless interruption of study medication was due to toxicity (e.g. DLT).
Adverse events (AEs) were graded using Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. DLTs included: Grade 4 neutropenia lasting for ≥7 days; Grade 3 or Grade 4 neutropenia with fever \>38.5ºC and/or infection requiring antibiotic or anti-fungal treatment; Grade 4 thrombocytopenia (≤25.0 x 10\^9/L); Grade ≥3 non-hematologic toxicity with exceptions; Any drug-related AE, regardless of CTCAE Grade, leading to a dose modification of MK-2206 or AZD6244; Unresolved CTCAE Grade ≥3 drug-related toxicity requiring drug interruption for \>14 days; ≥ Grade 3 signs or symptoms of glucose intolerance and accompanied by ≥ Grade 2 hyperglycemia (glucose \>160 dL or 8.9 mmol/L); ≥ Grade 3 electrolyte abnormalities due to glucose intolerance and not attributable to another cause; Diagnosis of lactoacidosis or ketoacidosis; Persistent increases in corrected QT (QTc) interval (\>60 msec from baseline and/or \>500 msec); Clinically significant bradycardia.
Outcome measures
| Measure |
MK-2206 45 mg QOD + AZD6244 75 mg QD
n=6 Participants
Participants received MK-2206 45 mg oral tablets QOD PLUS AZD6244 75 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 45 mg QOD + AZD6244 75 mg BID
n=4 Participants
Participants received MK-2206 45 mg oral tablets QOD PLUS AZD6244 75 mg oral capsules BID starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 50 mg BID
n=7 Participants
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 50 mg oral capsules BID starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 75 mg QD
n=7 Participants
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 75 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 75 mg BID
n=9 Participants
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 75 mg oral capsules BID starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 100 mg QD
n=3 Participants
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 150 mg QD
n=3 Participants
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 150 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 100 mg QW + AZD6244 100 mg QD
n=6 Participants
Participants received MK-2206 100 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 135 mg QW + AZD6244 100 mg QD
n=17 Participants
Participants received MK-2206 135 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With a Dose-limiting Toxicity (DLT)
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 23 monthsPopulation: The population consisted of all participants who received at least one dose of study treatment.
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of the product. Any worsening of a pre-existing condition which was temporally associated with the use of study drug was also an AE. The number of participants who experienced at least one AE is presented.
Outcome measures
| Measure |
MK-2206 45 mg QOD + AZD6244 75 mg QD
n=6 Participants
Participants received MK-2206 45 mg oral tablets QOD PLUS AZD6244 75 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 45 mg QOD + AZD6244 75 mg BID
n=4 Participants
Participants received MK-2206 45 mg oral tablets QOD PLUS AZD6244 75 mg oral capsules BID starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 50 mg BID
n=7 Participants
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 50 mg oral capsules BID starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 75 mg QD
n=7 Participants
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 75 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 75 mg BID
n=9 Participants
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 75 mg oral capsules BID starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 100 mg QD
n=3 Participants
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 150 mg QD
n=3 Participants
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 150 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 100 mg QW + AZD6244 100 mg QD
n=6 Participants
Participants received MK-2206 100 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 135 mg QW + AZD6244 100 mg QD
n=17 Participants
Participants received MK-2206 135 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced at Least One Adverse Event (AE)
|
6 Participants
|
4 Participants
|
7 Participants
|
7 Participants
|
9 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 20 monthsPopulation: The population consisted of all participants who received at least one dose of study treatment.
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of the product. Any worsening of a pre-existing condition which was temporally associated with the use of study drug was also an AE. The number of participants who discontinued study treatment due to an AE is presented.
Outcome measures
| Measure |
MK-2206 45 mg QOD + AZD6244 75 mg QD
n=6 Participants
Participants received MK-2206 45 mg oral tablets QOD PLUS AZD6244 75 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 45 mg QOD + AZD6244 75 mg BID
n=4 Participants
Participants received MK-2206 45 mg oral tablets QOD PLUS AZD6244 75 mg oral capsules BID starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 50 mg BID
n=7 Participants
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 50 mg oral capsules BID starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 75 mg QD
n=7 Participants
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 75 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 75 mg BID
n=9 Participants
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 75 mg oral capsules BID starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 100 mg QD
n=3 Participants
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 150 mg QD
n=3 Participants
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 150 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 100 mg QW + AZD6244 100 mg QD
n=6 Participants
Participants received MK-2206 100 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 135 mg QW + AZD6244 100 mg QD
n=17 Participants
Participants received MK-2206 135 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Treatment Due to an AE
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline and after every 8 weeks of treatment until documentation of objective response or disease progression (Up to 2 years)Population: The analysis population consisted of all participants with assessable disease at baseline or measureable disease at baseline per RECIST1.1.
Radiological evaluation (via computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) of tumor response was assessed every 8 weeks post-treatment during Cycles 1-6, and per institutional standard of care in Cycle 7 and beyond. The best overall tumor response was the best response based on RECIST 1.1 recorded from the start of the study treatment until the end of treatment. Response categories included: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions; and Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Participants whose tumor was not evaluable (NE) were missing a valid RECIST1.1 measurement at baseline. The best overall tumor response for participants is presented.
Outcome measures
| Measure |
MK-2206 45 mg QOD + AZD6244 75 mg QD
n=6 Participants
Participants received MK-2206 45 mg oral tablets QOD PLUS AZD6244 75 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 45 mg QOD + AZD6244 75 mg BID
n=3 Participants
Participants received MK-2206 45 mg oral tablets QOD PLUS AZD6244 75 mg oral capsules BID starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 50 mg BID
n=7 Participants
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 50 mg oral capsules BID starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 75 mg QD
n=7 Participants
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 75 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 75 mg BID
n=9 Participants
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 75 mg oral capsules BID starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 100 mg QD
n=3 Participants
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 150 mg QD
n=2 Participants
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 150 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 100 mg QW + AZD6244 100 mg QD
n=6 Participants
Participants received MK-2206 100 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 135 mg QW + AZD6244 100 mg QD
n=13 Participants
Participants received MK-2206 135 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With a Tumor Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Tumor Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Partial Response
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With a Tumor Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Stable Disease
|
4 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
10 Participants
|
|
Number of Participants With a Tumor Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Progressive Disease
|
2 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
Adverse Events
MK-2206 45 mg QOD + AZD6244 75 mg QD
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
MK-2206 45 mg QOD + AZD6244 75 mg BID
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
MK-2206 90 mg QW + AZD6244 50 mg BID
Serious events: 6 serious events
Other events: 7 other events
Deaths: 0 deaths
MK-2206 90 mg QW + AZD6244 75 mg QD
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
MK-2206 90 mg QW + AZD6244 75 mg BID
Serious events: 6 serious events
Other events: 9 other events
Deaths: 0 deaths
MK-2206 90 mg QW + AZD6244 100 mg QD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MK-2206 90 mg QW + AZD6244 150 mg QD
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
MK-2206 100 mg QW + AZD6244 100 mg QD
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
MK-2206 135 mg QW + AZD6244 100 mg QD
Serious events: 5 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MK-2206 45 mg QOD + AZD6244 75 mg QD
n=6 participants at risk
Participants received MK-2206 45 mg oral tablets QOD PLUS AZD6244 75 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 45 mg QOD + AZD6244 75 mg BID
n=4 participants at risk
Participants received MK-2206 45 mg oral tablets QOD PLUS AZD6244 75 mg oral capsules BID starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 50 mg BID
n=7 participants at risk
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 50 mg oral capsules BID starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 75 mg QD
n=7 participants at risk
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 75 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 75 mg BID
n=9 participants at risk
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 75 mg oral capsules BID starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 100 mg QD
n=3 participants at risk
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 150 mg QD
n=3 participants at risk
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 150 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 100 mg QW + AZD6244 100 mg QD
n=6 participants at risk
Participants received MK-2206 100 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 135 mg QW + AZD6244 100 mg QD
n=17 participants at risk
Participants received MK-2206 135 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
22.2%
2/9 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Eye disorders
Detachment of retinal pigment epithelium
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
28.6%
2/7 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
28.6%
2/7 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Meningitis
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Renal haematoma
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Lipase increased
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Complex partial seizures
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
Other adverse events
| Measure |
MK-2206 45 mg QOD + AZD6244 75 mg QD
n=6 participants at risk
Participants received MK-2206 45 mg oral tablets QOD PLUS AZD6244 75 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 45 mg QOD + AZD6244 75 mg BID
n=4 participants at risk
Participants received MK-2206 45 mg oral tablets QOD PLUS AZD6244 75 mg oral capsules BID starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 50 mg BID
n=7 participants at risk
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 50 mg oral capsules BID starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 75 mg QD
n=7 participants at risk
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 75 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 75 mg BID
n=9 participants at risk
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 75 mg oral capsules BID starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 100 mg QD
n=3 participants at risk
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 90 mg QW + AZD6244 150 mg QD
n=3 participants at risk
Participants received MK-2206 90 mg oral tablets QW PLUS AZD6244 150 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 100 mg QW + AZD6244 100 mg QD
n=6 participants at risk
Participants received MK-2206 100 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
MK-2206 135 mg QW + AZD6244 100 mg QD
n=17 participants at risk
Participants received MK-2206 135 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Madarosis
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
2/6 • Number of events 4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
28.6%
2/7 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
22.2%
2/9 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
66.7%
2/3 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
41.2%
7/17 • Number of events 9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
100.0%
6/6 • Number of events 9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
75.0%
3/4 • Number of events 8 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
42.9%
3/7 • Number of events 5 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
55.6%
5/9 • Number of events 9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
100.0%
3/3 • Number of events 7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
66.7%
4/6 • Number of events 13 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
52.9%
9/17 • Number of events 20 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
17.6%
3/17 • Number of events 7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
17.6%
3/17 • Number of events 7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.8%
2/17 • Number of events 5 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.8%
2/17 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.8%
2/17 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic cough
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
3/9 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
66.7%
2/3 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
17.6%
3/17 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
50.0%
2/4 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.8%
2/17 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
28.6%
2/7 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
23.5%
4/17 • Number of events 5 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
28.6%
2/7 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.8%
2/17 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
50.0%
2/4 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
71.4%
5/7 • Number of events 10 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
57.1%
4/7 • Number of events 6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
3/9 • Number of events 5 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
35.3%
6/17 • Number of events 10 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
50.0%
3/6 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
28.6%
2/7 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
28.6%
2/7 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
66.7%
2/3 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
35.3%
6/17 • Number of events 8 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema annulare
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
28.6%
2/7 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.8%
2/17 • Number of events 7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
28.6%
2/7 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.8%
2/17 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.8%
2/17 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Auricular swelling
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Eye disorders
Amblyopia
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Eye disorders
Blepharitis
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Eye disorders
Cataract
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Eye disorders
Cataract subcapsular
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Eye disorders
Detachment of macular retinal pigment epithelium
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Eye disorders
Dry eye
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Eye disorders
Eye pain
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Eye disorders
Eye swelling
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
17.6%
3/17 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Eye disorders
Macular fibrosis
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Eye disorders
Macular pigmentation
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Eye disorders
Maculopathy
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Eye disorders
Ocular hypertension
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.8%
2/17 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Eye disorders
Photophobia
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Eye disorders
Retinal pigment epitheliopathy
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Eye disorders
Scleral hyperaemia
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Eye disorders
Vision blurred
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Eye disorders
Visual impairment
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
28.6%
2/7 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
22.2%
2/9 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
66.7%
2/3 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
2/6 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
28.6%
2/7 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
3/9 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
28.6%
2/7 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
22.2%
2/9 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
66.7%
2/3 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.8%
2/17 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
3/6 • Number of events 8 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
75.0%
3/4 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
42.9%
3/7 • Number of events 7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
42.9%
3/7 • Number of events 6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
55.6%
5/9 • Number of events 6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
100.0%
3/3 • Number of events 5 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
82.4%
14/17 • Number of events 20 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
23.5%
4/17 • Number of events 6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
3/9 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Faecal incontinence
|
16.7%
1/6 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Lip ulceration
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Mouth ulceration
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
71.4%
5/7 • Number of events 6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
57.1%
4/7 • Number of events 5 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
66.7%
2/3 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
50.0%
3/6 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
47.1%
8/17 • Number of events 13 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
2/6 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
55.6%
5/9 • Number of events 7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
17.6%
3/17 • Number of events 4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
100.0%
7/7 • Number of events 10 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
57.1%
4/7 • Number of events 4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
66.7%
2/3 • Number of events 4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
50.0%
3/6 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
23.5%
4/17 • Number of events 4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Axillary pain
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Chest discomfort
|
16.7%
1/6 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Chest pain
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Chills
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Face oedema
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Fatigue
|
50.0%
3/6 • Number of events 6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
57.1%
4/7 • Number of events 11 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
42.9%
3/7 • Number of events 4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
3/9 • Number of events 6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
66.7%
2/3 • Number of events 4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
50.0%
3/6 • Number of events 4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
64.7%
11/17 • Number of events 15 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Localised oedema
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Malaise
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
42.9%
3/7 • Number of events 7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
41.2%
7/17 • Number of events 10 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Oedema
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Pain
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Cystitis
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Ear infection
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Eyelid infection
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Infection
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Paronychia
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.8%
2/17 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Rhinitis
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
28.6%
2/7 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
23.5%
4/17 • Number of events 5 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Nail injury
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
22.2%
2/9 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
17.6%
3/17 • Number of events 7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
22.2%
2/9 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
23.5%
4/17 • Number of events 6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
42.9%
3/7 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 10 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
17.6%
3/17 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Blood glucose increased
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Blood urea increased
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Culture urine positive
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Electrocardiogram T wave amplitude decreased
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Haemoglobin
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Weight decreased
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
42.9%
3/7 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
66.7%
2/3 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
23.5%
4/17 • Number of events 8 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
28.6%
2/7 • Number of events 5 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.8%
2/17 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
17.6%
3/17 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
28.6%
2/7 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
17.6%
3/17 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
22.2%
2/9 • Number of events 5 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
28.6%
2/7 • Number of events 4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Brachial plexopathy
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 5 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
22.2%
2/9 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.8%
2/17 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
28.6%
2/7 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
29.4%
5/17 • Number of events 6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Migraine
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
17.6%
3/17 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Haematuria
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/17 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hot flush
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
17.6%
3/17 • Number of events 3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/9 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
5.9%
1/17 • Number of events 1 • Up to approximately 23 months
The population consisted of all participants who received at least one dose of study treatment.
|
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.
- Publication restrictions are in place
Restriction type: OTHER