Trial Outcomes & Findings for Study of MK-8242 Alone and in Combination With Cytarabine in Participants With Acute Myelogenous Leukemia (P07649) (NCT NCT01451437)
NCT ID: NCT01451437
Last Updated: 2018-08-27
Results Overview
DLTs were identified using Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0 for toxicities attributable to the study drug. Hematologic DLTs were defined in the absence of morphological evidence of acute leukemia in the marrow if 1) bone marrow: aplastic marrow with \<5% cellularity without erythroid, myeloid, or megakaryocytic precursors and 2) peripheral blood: absolute neutrophil count (ANC) \<100/µL, platelet count \<10,000/µL, and transfusion-dependent anemia. Non-hematologic DLTs were defined as any ≥Grade 3 toxicity with the following exceptions/clarifications: 1) infection, fatigue, anorexia, or alopecia are not included in determination of the DLT 2) Grade 3 nausea, vomiting, diarrhea, or dehydration occurring in a setting of inadequate treatment 3) any abnormal non-hematological laboratory value ≥Grade 3 will be considered a DLT after 72 hours of appropriate medical intervention if not related to an underlying disease or not attributable to another event.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
Up to 28 days (Cycle 1) for non-hematologic toxicities and 42 days (Cycle 1) for hematologic toxicities
Results posted on
2018-08-27
Participant Flow
No participant in Part 1 received combination therapy (MK-8242 + cytarabine). Study Part 2 was not performed due to early termination of the study.
Participant milestones
| Measure |
Pt 1 Arm A: MK-8242 30 mg QD
Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 60 mg QD
Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 120 mg QD
Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 250 mg QD
Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 120 mg BID
Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 170 mg BID
Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 210 mg BID
Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 250 mg BID
Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 300 mg BID
Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
3
|
1
|
4
|
3
|
6
|
3
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
3
|
1
|
4
|
3
|
6
|
3
|
4
|
Reasons for withdrawal
| Measure |
Pt 1 Arm A: MK-8242 30 mg QD
Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 60 mg QD
Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 120 mg QD
Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 250 mg QD
Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 120 mg BID
Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 170 mg BID
Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 210 mg BID
Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 250 mg BID
Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 300 mg BID
Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
2
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Disease Progression
|
0
|
0
|
1
|
1
|
3
|
2
|
3
|
1
|
3
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Study of MK-8242 Alone and in Combination With Cytarabine in Participants With Acute Myelogenous Leukemia (P07649)
Baseline characteristics by cohort
| Measure |
Pt 1 Arm A: MK-8242 30 mg QD
n=1 Participants
Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 60 mg QD
n=1 Participants
Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 120 mg QD
n=3 Participants
Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 250 mg QD
n=1 Participants
Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 120 mg BID
n=4 Participants
Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 170 mg BID
n=3 Participants
Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 210 mg BID
n=6 Participants
Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 250 mg BID
n=3 Participants
Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 300 mg BID
n=4 Participants
Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
63.0 Years
STANDARD_DEVIATION NA • n=5 Participants
|
74.0 Years
STANDARD_DEVIATION NA • n=7 Participants
|
72.3 Years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
77.0 Years
STANDARD_DEVIATION NA • n=4 Participants
|
58.8 Years
STANDARD_DEVIATION 18.5 • n=21 Participants
|
63.3 Years
STANDARD_DEVIATION 14.6 • n=8 Participants
|
63.5 Years
STANDARD_DEVIATION 11.5 • n=8 Participants
|
72.3 Years
STANDARD_DEVIATION 12.5 • n=24 Participants
|
41.0 Years
STANDARD_DEVIATION 14.3 • n=42 Participants
|
62.2 Years
STANDARD_DEVIATION 15.5 • n=42 Participants
|
|
Age, Customized
Adults between 18 and 64 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
|
Age, Customized
From 65 to 84 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
20 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
24 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Hispanic Or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic Or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
22 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Up to 28 days (Cycle 1) for non-hematologic toxicities and 42 days (Cycle 1) for hematologic toxicitiesPopulation: DLT-evaluable Population: participants who received at least one dose of MK-8242 and completed Cycle 1 of Part 1 or discontinued due to reason of toxicity.
DLTs were identified using Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0 for toxicities attributable to the study drug. Hematologic DLTs were defined in the absence of morphological evidence of acute leukemia in the marrow if 1) bone marrow: aplastic marrow with \<5% cellularity without erythroid, myeloid, or megakaryocytic precursors and 2) peripheral blood: absolute neutrophil count (ANC) \<100/µL, platelet count \<10,000/µL, and transfusion-dependent anemia. Non-hematologic DLTs were defined as any ≥Grade 3 toxicity with the following exceptions/clarifications: 1) infection, fatigue, anorexia, or alopecia are not included in determination of the DLT 2) Grade 3 nausea, vomiting, diarrhea, or dehydration occurring in a setting of inadequate treatment 3) any abnormal non-hematological laboratory value ≥Grade 3 will be considered a DLT after 72 hours of appropriate medical intervention if not related to an underlying disease or not attributable to another event.
Outcome measures
| Measure |
Pt 1 Arm A: MK-8242 30 mg QD
n=1 Participants
Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 60 mg QD
n=1 Participants
Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 120 mg QD
n=3 Participants
Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 250 mg QD
n=1 Participants
Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 120 mg BID
n=4 Participants
Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 170 mg BID
n=3 Participants
Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 210 mg BID
n=6 Participants
Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 250 mg BID
n=3 Participants
Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 300 mg BID
n=4 Participants
Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: End of Treatment (up to 198 days)Population: Full Analysis Set for Efficacy: all participants with confirmed p53 wild type (WT) status who received at least one dose of MK-8242 and have at least one baseline and one post-baseline efficacy assessment.
Clinical activity of MK-8242 given as monotherapy in participants with refractory or recurrent AML measured as participants who achieved CR according to Cheson (2003) criteria at the RP2D. The outcome analysis was not performed since the RP2D for MK-8242 monotherapy could not be established due to early termination of the study.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: End of Treatment (up to 198 days)Population: Full Analysis Set for Efficacy: all participants with confirmed p53 WT status who received at least one dose of MK-8242 and have at least one baseline and one post-baseline efficacy assessment.
Clinical activity of MK-8242 given as monotherapy in participants with refractory or recurrent AML measured as participants who achieved CRi according to Cheson (2003) criteria at the RP2D. The outcome analysis was not performed since the RP2D for MK-8242 monotherapy could not be established due to early termination of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: End of Treatment (up to 198 days)Population: Modified Full Analysis Set for Efficacy: all participants with confirmed p53 WT status who received at least one dose of MK-8242.
Clinical activity of MK-8242 given as monotherapy in participants with refractory or recurrent AML measured as participants who achieved CR according to Cheson (2003) criteria at dose levels other than RP2D. CR is defined as a morphologic leukemia-free state with a neutrophil count ≥1,000/µL, a platelet count ≥100,000/µL, no extramedullary disease, and RBC transfusion independence. Presented outcome values are not stratified for dose levels other than RP2D; the RP2D for MK-8242 monotherapy could not be established due to early termination of the study.
Outcome measures
| Measure |
Pt 1 Arm A: MK-8242 30 mg QD
n=1 Participants
Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 60 mg QD
n=1 Participants
Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 120 mg QD
n=3 Participants
Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 250 mg QD
n=1 Participants
Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 120 mg BID
n=4 Participants
Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 170 mg BID
n=3 Participants
Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 210 mg BID
n=6 Participants
Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 250 mg BID
n=3 Participants
Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 300 mg BID
n=4 Participants
Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With CR at Dose Levels Other Than RP2D
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: End of Treatment (up to 198 days)Population: Modified Full Analysis Set for Efficacy: all participants with confirmed p53 WT status who received at least one dose of MK-8242.
Clinical activity of MK-8242 given as monotherapy in participants with refractory or recurrent AML measured as participants who achieved CRi according to Cheson (2003) criteria at dose levels other than RP2D. CRi is defined as fulfillment of all CR criteria with exceptions for residual neutropenia (\<1,000/µL), thrombocytopenia (\<100,000/µL), and RBC transfusion dependence. Presented outcome values are not stratified for dose levels other than RP2D; the RP2D for MK-8242 monotherapy could not be established due to early termination of the study.
Outcome measures
| Measure |
Pt 1 Arm A: MK-8242 30 mg QD
n=1 Participants
Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 60 mg QD
n=1 Participants
Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 120 mg QD
n=3 Participants
Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 250 mg QD
n=1 Participants
Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 120 mg BID
n=4 Participants
Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 170 mg BID
n=3 Participants
Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 210 mg BID
n=6 Participants
Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 250 mg BID
n=3 Participants
Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 300 mg BID
n=4 Participants
Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With CRi at Dose Levels Other Than RP2D
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 and Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, and 24 hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], and 24 [Day 7 only] hrs postdose)Population: Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (AUC0-24hr) at the time of assessment.
AUC(0-24hr) defined as AUC from time zero to 24 hours was determined for Cycle 1 Days 1 and 7 of MK-8242 QD and BID dosing using the trapezoidal up/log trapezoidal down method. For the BID arms, a projection beyond the last sampled time was made if a linear terminal elimination phase half-life was identified with three time-points after Tmax. Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).
Outcome measures
| Measure |
Pt 1 Arm A: MK-8242 30 mg QD
n=1 Participants
Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 60 mg QD
n=1 Participants
Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 120 mg QD
n=3 Participants
Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 250 mg QD
n=1 Participants
Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 120 mg BID
n=4 Participants
Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 170 mg BID
n=3 Participants
Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 210 mg BID
n=5 Participants
Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 250 mg BID
n=3 Participants
Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 300 mg BID
n=3 Participants
Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24hr) for MK-8242 Alone and in Combination With Cytarabine
Day 1 (n=1,1,3,1,3,2,4,3,1)
|
604 hr*nM
Geometric Coefficient of Variation NA
n/a: not calculated for n=1
|
510 hr*nM
Geometric Coefficient of Variation NA
n/a: not calculated for n=1
|
3710 hr*nM
Geometric Coefficient of Variation 126
|
10900 hr*nM
Geometric Coefficient of Variation NA
n/a: not calculated for n=1
|
3230 hr*nM
Geometric Coefficient of Variation 101
|
6940 hr*nM
Geometric Coefficient of Variation 127.0
|
6400 hr*nM
Geometric Coefficient of Variation 76.4
|
7910 hr*nM
Geometric Coefficient of Variation 81.5
|
9480 hr*nM
Geometric Coefficient of Variation NA
n/a: not calculated for n=1
|
|
Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24hr) for MK-8242 Alone and in Combination With Cytarabine
Day 7 (n=1,1,3,1,3,3,5,3,3)
|
665 hr*nM
Geometric Coefficient of Variation NA
n/a: not calculated for n=1
|
515 hr*nM
Geometric Coefficient of Variation NA
n/a: not calculated for n=1
|
3460 hr*nM
Geometric Coefficient of Variation 54.6
|
6840 hr*nM
Geometric Coefficient of Variation NA
n/a: not calculated for n=1
|
4180 hr*nM
Geometric Coefficient of Variation 41.2
|
8440 hr*nM
Geometric Coefficient of Variation 105
|
11200 hr*nM
Geometric Coefficient of Variation 53.0
|
8800 hr*nM
Geometric Coefficient of Variation 56.9
|
14200 hr*nM
Geometric Coefficient of Variation 62.5
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 and Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 [Day 7 only] hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24 [Day 7 only], 48 [Day 7 only] hrs postdose)Population: Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (AUC0-last) at the time of assessment.
AUC(0-last) defined as AUC from time zero to the time of last quantifiable sample was determined for Cycle 1 Days 1 and 7 of MK-8242 QD and BID dosing using the trapezoidal up/log trapezoidal down method. Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).
Outcome measures
| Measure |
Pt 1 Arm A: MK-8242 30 mg QD
n=1 Participants
Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 60 mg QD
n=1 Participants
Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 120 mg QD
n=3 Participants
Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 250 mg QD
n=1 Participants
Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 120 mg BID
n=4 Participants
Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 170 mg BID
n=3 Participants
Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 210 mg BID
n=5 Participants
Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 250 mg BID
n=3 Participants
Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 300 mg BID
n=3 Participants
Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time 0 to Last (AUC0-last) for MK-8242 Alone and in Combination With Cytarabine
Day 1
|
323 hr*nM
Geometric Coefficient of Variation NA
n/a: not calculated for n=1
|
482 hr*nM
Geometric Coefficient of Variation NA
n/a: not calculated for n=1
|
3420 hr*nM
Geometric Coefficient of Variation 156
|
10900 hr*nM
Geometric Coefficient of Variation NA
n/a: not calculated for n=1
|
2710 hr*nM
Geometric Coefficient of Variation 58.3
|
4370 hr*nM
Geometric Coefficient of Variation 111
|
5310 hr*nM
Geometric Coefficient of Variation 56.1
|
6710 hr*nM
Geometric Coefficient of Variation 76.3
|
7200 hr*nM
Geometric Coefficient of Variation 15.1
|
|
Area Under the Concentration-time Curve From Time 0 to Last (AUC0-last) for MK-8242 Alone and in Combination With Cytarabine
Day 7
|
470 hr*nM
Geometric Coefficient of Variation NA
n/a: not calculated for n=1
|
482 hr*nM
Geometric Coefficient of Variation NA
n/a: not calculated for n=1
|
3180 hr*nM
Geometric Coefficient of Variation 73.5
|
6830 hr*nM
Geometric Coefficient of Variation NA
n/a: not calculated for n=1
|
3100 hr*nM
Geometric Coefficient of Variation 73.1
|
9560 hr*nM
Geometric Coefficient of Variation 183
|
11900 hr*nM
Geometric Coefficient of Variation 59.8
|
9080 hr*nM
Geometric Coefficient of Variation 51.4
|
15200 hr*nM
Geometric Coefficient of Variation 74.1
|
SECONDARY outcome
Timeframe: Cycle 1 Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24, 48 hrs postdose)Population: Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (AUC0-∞) at the time of assessment.
AUC0-∞ defined as AUC from time zero to infinity was determined for Cycle 1 Day 7 of MK-8242 QD and BID dosing using the trapezoidal up/log trapezoidal down method. Projection beyond the last sampled time was made if a linear terminal elimination phase half-life was identified with three time-points after Tmax (condition not met for 60 QD and 120 BID dose groups). Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).
Outcome measures
| Measure |
Pt 1 Arm A: MK-8242 30 mg QD
n=1 Participants
Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 60 mg QD
Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 120 mg QD
n=3 Participants
Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 250 mg QD
n=1 Participants
Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 120 mg BID
Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 170 mg BID
n=1 Participants
Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 210 mg BID
n=3 Participants
Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 250 mg BID
n=2 Participants
Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 300 mg BID
n=2 Participants
Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) for MK-8242 Alone and in Combination With Cytarabine
|
650 hr*nM
Geometric Coefficient of Variation NA
n/a: not calculated for n=1
|
—
|
3570 hr*nM
Geometric Coefficient of Variation 61.6
|
6990 hr*nM
Geometric Coefficient of Variation NA
n/a: not calculated for n=1
|
—
|
6480 hr*nM
Geometric Coefficient of Variation NA
n/a: not calculated for n=1
|
13300 hr*nM
Geometric Coefficient of Variation 84.2
|
11700 hr*nM
Geometric Coefficient of Variation 40.3
|
15100 hr*nM
Geometric Coefficient of Variation 112.0
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 and Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 [Day 7 only] hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24 [Day 7 only], 48 [Day 7 only] hrs postdose)Population: Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (Cmax) at the time of assessment.
Cmax was determined for Cycle 1 Days 1 and 7 of MK-8226 QD and BID dosing. Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).
Outcome measures
| Measure |
Pt 1 Arm A: MK-8242 30 mg QD
n=1 Participants
Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 60 mg QD
n=1 Participants
Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 120 mg QD
n=3 Participants
Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 250 mg QD
n=1 Participants
Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 120 mg BID
n=4 Participants
Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 170 mg BID
n=3 Participants
Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 210 mg BID
n=5 Participants
Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 250 mg BID
n=3 Participants
Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 300 mg BID
n=3 Participants
Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of MK-8242 Alone and in Combination With Cytarabine
Day 1 (n=1,1,3,1,4,3,5,3,3)
|
56.7 nM
Geometric Coefficient of Variation NA
n/a: not calculated for n=1
|
109 nM
Geometric Coefficient of Variation NA
n/a: not calculated for n=1
|
416 nM
Geometric Coefficient of Variation 81.4
|
1270 nM
Geometric Coefficient of Variation NA
n/a: not calculated for n=1
|
561 nM
Geometric Coefficient of Variation 51.9
|
984 nM
Geometric Coefficient of Variation 93.2
|
1310 nM
Geometric Coefficient of Variation 52.5
|
1510 nM
Geometric Coefficient of Variation 65.7
|
1940 nM
Geometric Coefficient of Variation 25.8
|
|
Maximum Plasma Concentration (Cmax) of MK-8242 Alone and in Combination With Cytarabine
Day 7 (n=1,1,3,1,3,3,5,3,3)
|
88.8 nM
Geometric Coefficient of Variation NA
n/a: not calculated for n=1
|
178 nM
Geometric Coefficient of Variation NA
n/a: not calculated for n=1
|
530 nM
Geometric Coefficient of Variation 55.9
|
1320 nM
Geometric Coefficient of Variation NA
n/a: not calculated for n=1
|
744 nM
Geometric Coefficient of Variation 56.1
|
1200 nM
Geometric Coefficient of Variation 65.2
|
1550 nM
Geometric Coefficient of Variation 50.7
|
1500 nM
Geometric Coefficient of Variation 108
|
1920 nM
Geometric Coefficient of Variation 80.8
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 and Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 [Day 7 only] hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24 [Day 7 only], 48 [Day 7 only] hrs postdose)Population: Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (Tmax) at the time of assessment.
Tmax was determined for Cycle 1 Days 1 and 7 of MK-8226 QD and BID dosing. Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).
Outcome measures
| Measure |
Pt 1 Arm A: MK-8242 30 mg QD
n=1 Participants
Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 60 mg QD
n=1 Participants
Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 120 mg QD
n=3 Participants
Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 250 mg QD
n=1 Participants
Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 120 mg BID
n=4 Participants
Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 170 mg BID
n=3 Participants
Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 210 mg BID
n=5 Participants
Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 250 mg BID
n=3 Participants
Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 300 mg BID
n=3 Participants
Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
|
|---|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Concentration (Tmax) of MK-8242 Alone and in Combination With Cytarabine
Day 1 (n=1,1,3,1,4,3,5,3,3)
|
6.25 Hours
n/a: not calculated for n=1
|
2.00 Hours
n/a: not calculated for n=1
|
4.00 Hours
Interval 2.08 to 4.05
|
4.00 Hours
n/a: not calculated for n=1
|
4.00 Hours
Interval 2.12 to 4.0
|
2.00 Hours
Interval 2.0 to 4.13
|
2.00 Hours
Interval 1.87 to 4.08
|
2.00 Hours
Interval 2.0 to 4.0
|
2.08 Hours
Interval 2.0 to 6.0
|
|
Time to Maximum Concentration (Tmax) of MK-8242 Alone and in Combination With Cytarabine
Day 7 (n=1,1,3,1,3,3,5,3,3)
|
2.00 Hours
n/a: not calculated for n=1
|
2.00 Hours
n/a: not calculated for n=1
|
2.00 Hours
Interval 1.0 to 2.0
|
2.00 Hours
n/a: not calculated for n=1
|
4.00 Hours
Interval 2.0 to 4.0
|
4.15 Hours
Interval 2.25 to 6.0
|
4.00 Hours
Interval 2.0 to 6.0
|
2.00 Hours
Interval 1.92 to 4.08
|
4.00 Hours
Interval 4.0 to 6.0
|
SECONDARY outcome
Timeframe: Cycle 1 Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24, 48 hrs postdose)Population: Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (at least three time-points after Tmax).
Elimination phase t1/2 was determined for Cycle 1 Day 7 of MK-8242 QD and BID dosing. Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).
Outcome measures
| Measure |
Pt 1 Arm A: MK-8242 30 mg QD
n=1 Participants
Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 60 mg QD
Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 120 mg QD
n=3 Participants
Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 250 mg QD
n=1 Participants
Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 120 mg BID
Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 170 mg BID
n=1 Participants
Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 210 mg BID
n=3 Participants
Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 250 mg BID
n=2 Participants
Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 300 mg BID
n=2 Participants
Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
|
|---|---|---|---|---|---|---|---|---|---|
|
Apparent Terminal Half-life (t1/2) for MK-8242 Alone and in Combination With Cytarabine
|
4.7 hr
Geometric Coefficient of Variation NA
n/a: not calculated for n=1
|
—
|
5.33 hr
Geometric Coefficient of Variation 23.5
|
4.57 hr
Geometric Coefficient of Variation NA
n/a: not calculated for n=1
|
—
|
10.30 hr
Geometric Coefficient of Variation NA
n/a: not calculated for n=1
|
7.92 hr
Geometric Coefficient of Variation 31.6
|
5.21 hr
Geometric Coefficient of Variation 17.9
|
7.06 hr
Geometric Coefficient of Variation 36.6
|
SECONDARY outcome
Timeframe: Cycle 1 Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24 [Day 7 only], 48 [Day 7 only] hrs postdose)Population: Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (R) at the time of assessment.
The accumulation ratio (R) at steady state (based on dosing interval and apparent terminal half-life (t1/2)) for MK-8242 alone was not determined due to confounding of results by significant concentrations of a drug metabolite (M16). Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 (predose and postdose) and Day 7 (postdose)Population: Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (urine concentration) at the time of assessment
The urine concentration of MK-8242 assessed as a measure of drug bioavailability was not determined due to early termination of the study (Study Part 2 was not performed).
Outcome measures
Outcome data not reported
Adverse Events
Pt 1 Arm A: MK-8242 30 mg QD
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Pt 1 Arm A: MK-8242 60 mg QD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Pt 1 Arm A: MK-8242 120 mg QD
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Pt 1 Arm A: MK-8242 250 mg QD
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Pt 1 Arm A: MK-8242 120 mg BID
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Pt 1 Arm A: MK-8242 170 mg BID
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Pt 1 Arm A: MK-8242 210 mg BID
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Pt 1 Arm A: MK-8242 250 mg BID
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Pt 1 Arm A: MK-8242 300 mg BID
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pt 1 Arm A: MK-8242 30 mg QD
n=1 participants at risk
Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 60 mg QD
n=1 participants at risk
Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 120 mg QD
n=3 participants at risk
Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 250 mg QD
n=1 participants at risk
Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 120 mg BID
n=4 participants at risk
Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 170 mg BID
n=3 participants at risk
Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 210 mg BID
n=6 participants at risk
Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 250 mg BID
n=3 participants at risk
Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 300 mg BID
n=4 participants at risk
Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
|
|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
2/6 • Number of events 3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
100.0%
3/3 • Number of events 3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Cardiac disorders
Extrasystoles
|
100.0%
1/1 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Infections and infestations
Lung infection
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Infections and infestations
Pneumonia
|
100.0%
1/1 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
66.7%
2/3 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Infections and infestations
Sepsis
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
100.0%
1/1 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Psychiatric disorders
Depression
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
100.0%
1/1 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
100.0%
1/1 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
100.0%
1/1 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
Other adverse events
| Measure |
Pt 1 Arm A: MK-8242 30 mg QD
n=1 participants at risk
Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 60 mg QD
n=1 participants at risk
Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 120 mg QD
n=3 participants at risk
Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 250 mg QD
n=1 participants at risk
Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 120 mg BID
n=4 participants at risk
Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 170 mg BID
n=3 participants at risk
Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 210 mg BID
n=6 participants at risk
Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 250 mg BID
n=3 participants at risk
Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
|
Pt 1 Arm A: MK-8242 300 mg BID
n=4 participants at risk
Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
|
|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Pain
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
General disorders
Pyrexia
|
100.0%
1/1 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
66.7%
2/3 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Blood and lymphatic system disorders
Leukopenia
|
100.0%
1/1 • Number of events 3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 5 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Eye disorders
Photophobia
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
1/1 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
66.7%
2/3 • Number of events 3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
66.7%
2/3 • Number of events 6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
100.0%
1/1 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
100.0%
1/1 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
50.0%
2/4 • Number of events 3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
66.7%
4/6 • Number of events 4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
66.7%
2/3 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
50.0%
2/4 • Number of events 3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
2/6 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
100.0%
1/1 • Number of events 3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
50.0%
2/4 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
2/6 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
100.0%
3/3 • Number of events 4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
General disorders
Asthenia
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
General disorders
Catheter site rash
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
100.0%
1/1 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
General disorders
Chest pain
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
General disorders
Chills
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
66.7%
2/3 • Number of events 3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
66.7%
2/3 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
100.0%
1/1 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
66.7%
2/3 • Number of events 3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
General disorders
Infusion site erythema
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
General disorders
Malaise
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
General disorders
Oedema
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
66.7%
2/3 • Number of events 3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Infections and infestations
Candida infection
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Infections and infestations
Fungal cystitis
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
100.0%
1/1 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
1/1 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
2/6 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Investigations
Blood creatinine decreased
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Investigations
Electrocardiogram QT prolonged
|
100.0%
1/1 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Investigations
International normalised ratio decreased
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Investigations
Weight decreased
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
100.0%
1/1 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
66.7%
2/3 • Number of events 3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
2/6 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
100.0%
1/1 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
50.0%
2/4 • Number of events 3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
66.7%
2/3 • Number of events 4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
100.0%
1/1 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
66.7%
2/3 • Number of events 3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
100.0%
1/1 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia cutis
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Nervous system disorders
Dizziness postural
|
100.0%
1/1 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
100.0%
1/1 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Nervous system disorders
Syncope
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
2/6 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Psychiatric disorders
Depression
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
100.0%
1/1 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
100.0%
1/1 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal haemorrhage
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
100.0%
1/1 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord disorder
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 2 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Vascular disorders
Embolism
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
16.7%
1/6 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Vascular disorders
Haematoma
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
100.0%
1/1 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
25.0%
1/4 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
66.7%
2/3 • Number of events 3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
33.3%
1/3 • Number of events 1 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/6 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/3 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
0.00%
0/4 • Up to approximately 7.6 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
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 Investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the Sponsor. The Investigator further agrees to provide to the Sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial.
- Publication restrictions are in place
Restriction type: OTHER