Trial Outcomes & Findings for Study of the JAK Inhibitor Ruxolitinib Administered Orally to Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera-Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia-Myelofibrosis (PET-MF) (NCT NCT01317875)
NCT ID: NCT01317875
Last Updated: 2025-08-22
Results Overview
DLT was defined as the occurrence of any of the following treatment-related toxicities, occurring through Day 28: Any grade ≥ 2 hemorrhagic event ; Any grade thrombocytopenia requiring PLT transfusion; PLT count \< 25x109/L\*; Grade 4 neutropenia (absolute neutrophil count \< 0.5x109/L)\*; Grade ≥ 3 febrile neutropenia\*; Grade ≥ 2 total serum bilirubin with coincident direct bilirubin ≥ 0.5 mg/dL; Grade 3 non-hematologic toxicity for ≥ 7 consecutive days; Grade 4 non-hematologic toxicity. In the dose escalation stage in the core study period, the starting does in both strata was 5mg bid. Successive cohorts of newly enrolled patients received increasing doses of ruxolitinib until the Maximum Safe Starting Dose (MSSD) was determined. Initially, only patients with PLT counts 75-99 x10\^9/L (stratum 1) were allowed to be enrolled. Once safety was established in stratum 1 at the first 2 dose cohorts, eligible population was further expanded to patients with PLT counts 50-74 x10\^9/L (stratum 2).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
69 participants
Primary outcome timeframe
28 days
Results posted on
2025-08-22
Participant Flow
The study was conducted from 03-Mar-2011 to 31-Dec-2019 globally. Participants with MF and baseline PLT of 75 to \< 100 × 109/L are enrolled in Stratum 1;and 50 to \< 75 × 109/L are enrolled in Stratum 2.. The study has a core period (up to week 24) consisting of 2 phases (dose escalation and safety expansion) followed by an extension period (up to 3 years). Participants received increasing doses of ruxolitinib until the Maximum Safe Starting Dose (MSSD) was determined
A total of 69 participants enrolled in the study with 44 in Stratum 1 (cohorts 1,2,3,4,5) and 25 in Stratum 2 (Cohorts 1,2,3).
Participant milestones
| Measure |
Stratum 1 : Cohort 1
Ruxolitinib was administered at 5 mg bid in Participants with baseline Platelet counts of 75-99x10\^9/L
|
Stratum 1 : Cohort 2
Ruxolitinib was administered at 5 mg q.AM / 10 mg q.PM in Participants with baseline Platelet counts of 75-99 x10\^9/L
|
Stratum 1 : Cohort 3
Ruxolitinib was administered to cohort 3 at 10 mg bid in Participants with baseline Platelet counts of 75-99 x10\^9/L
|
Stratum 1 : Cohort 4
Ruxolitinib was administered at 10 mg q.AM / 15 mg q.PM in Participants with baseline Platelet counts of 75-99 x10\^9/L
|
Stratum 1 : Cohort 5
Ruxolitinib was administered at 15 mg bid in Participants with baseline Platelet counts of 75-99 x10\^9/L
|
Stratum 2 : Cohort 1
Ruxolitinib was administered at 5 mg bid in participants with baseline Platelet counts of 50-74x10\^9/L
|
Stratum 2 : Cohort 2
Ruxolitinib was administered at 5 mg q.AM / 10 mg q.PM in participants with baseline Platelet counts of 50-74 x10\^9/L
|
Stratum 2 : Cohort 3
Ruxolitinib was administered at 10 mg bid in participants with baseline Platelet counts of 50-74 x10\^9/L
|
Stratum 2 : Cohort 4
Ruxolitinib was administered at 10 mg q.AM / 15 mg q.PM in participants with baseline Platelet counts of 50-74 x10\^9/L
|
Stratum 2 : Cohort 5
Ruxolitinib was administered at 15 mg bid in participants with baseline Platelet counts of 50-74 x10\^9/L
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
20
|
4
|
12
|
3
|
4
|
18
|
0
|
0
|
|
Overall Study
COMPLETED
|
2
|
1
|
11
|
2
|
3
|
1
|
2
|
3
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
9
|
2
|
9
|
2
|
2
|
15
|
0
|
0
|
Reasons for withdrawal
| Measure |
Stratum 1 : Cohort 1
Ruxolitinib was administered at 5 mg bid in Participants with baseline Platelet counts of 75-99x10\^9/L
|
Stratum 1 : Cohort 2
Ruxolitinib was administered at 5 mg q.AM / 10 mg q.PM in Participants with baseline Platelet counts of 75-99 x10\^9/L
|
Stratum 1 : Cohort 3
Ruxolitinib was administered to cohort 3 at 10 mg bid in Participants with baseline Platelet counts of 75-99 x10\^9/L
|
Stratum 1 : Cohort 4
Ruxolitinib was administered at 10 mg q.AM / 15 mg q.PM in Participants with baseline Platelet counts of 75-99 x10\^9/L
|
Stratum 1 : Cohort 5
Ruxolitinib was administered at 15 mg bid in Participants with baseline Platelet counts of 75-99 x10\^9/L
|
Stratum 2 : Cohort 1
Ruxolitinib was administered at 5 mg bid in participants with baseline Platelet counts of 50-74x10\^9/L
|
Stratum 2 : Cohort 2
Ruxolitinib was administered at 5 mg q.AM / 10 mg q.PM in participants with baseline Platelet counts of 50-74 x10\^9/L
|
Stratum 2 : Cohort 3
Ruxolitinib was administered at 10 mg bid in participants with baseline Platelet counts of 50-74 x10\^9/L
|
Stratum 2 : Cohort 4
Ruxolitinib was administered at 10 mg q.AM / 15 mg q.PM in participants with baseline Platelet counts of 50-74 x10\^9/L
|
Stratum 2 : Cohort 5
Ruxolitinib was administered at 15 mg bid in participants with baseline Platelet counts of 50-74 x10\^9/L
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Other
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Noncompliance with study drug
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Progressive Disease
|
1
|
0
|
2
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
3
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
1
|
0
|
2
|
0
|
0
|
2
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
2
|
1
|
0
|
1
|
0
|
4
|
0
|
0
|
|
Overall Study
Adverse Event
|
2
|
1
|
2
|
1
|
5
|
1
|
2
|
5
|
0
|
0
|
Baseline Characteristics
Study of the JAK Inhibitor Ruxolitinib Administered Orally to Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera-Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia-Myelofibrosis (PET-MF)
Baseline characteristics by cohort
| Measure |
Stratum 1 : Cohort 1
n=5 Participants
Ruxolitinib was administered at 5 mg bid in Participants with baseline Platelet counts of 75-99x10\^9/L
|
Stratum 1 : Cohort 2
n=3 Participants
Ruxolitinib was administered at 5 mg q.AM / 10 mg q.PM in Participants with baseline Platelet counts of 75-99 x10\^9/L
|
Stratum 1 : Cohort 3
n=20 Participants
Ruxolitinib was administered to cohort 3 at 10 mg bid in Participants with baseline Platelet counts of 75-99 x10\^9/L
|
Stratum 1 : Cohort 4
n=4 Participants
Ruxolitinib was administered at 10 mg q.AM / 15 mg q.PM) in Participants with baseline Platelet counts of 75-99 x10\^9/L
|
Stratum 1 : Cohort 5
n=12 Participants
Ruxolitinib was administered at 15 mg bid in Participants with baseline Platelet counts of 75-99 x10\^9/L
|
Stratum 2 : Cohort 1
n=3 Participants
Ruxolitinib was administered at 5 mg bid in participants with baseline Platelet counts of 50-74x10\^9/L
|
Stratum 2 : Cohort 2
n=4 Participants
Ruxolitinib was administered at 5 mg q.AM / 10 mg q.PM) in participants with baseline Platelet counts of 50-74 x10\^9/L
|
Stratum 2 : Cohort 3
n=18 Participants
Ruxolitinib was administered at 10 mg bid in participants with baseline Platelet counts of 50-74 x10\^9/L
|
Stratum 2 : Cohort 4
Ruxolitinib was administered at 10 mg q.AM / 15 mg q.PM in participants with baseline Platelet counts of 50-74 x10\^9/L
|
Stratum 2 : Cohort 5
Ruxolitinib was administered at 15 mg bid in participants with baseline Platelet counts of 50-74 x10\^9/L
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
63.00 years
STANDARD_DEVIATION 7.78 • n=5 Participants
|
54.00 years
STANDARD_DEVIATION 4.00 • n=7 Participants
|
63.0 years
STANDARD_DEVIATION 14.71 • n=5 Participants
|
70.4 years
STANDARD_DEVIATION 8.91 • n=4 Participants
|
75.8 years
STANDARD_DEVIATION 3.30 • n=21 Participants
|
67.3 years
STANDARD_DEVIATION 11.06 • n=8 Participants
|
72.5 years
STANDARD_DEVIATION 6.95 • n=8 Participants
|
68.0 years
STANDARD_DEVIATION 11.66 • n=24 Participants
|
—
|
—
|
66.4 years
STANDARD_DEVIATION 11.81 • n=42 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
—
|
—
|
36 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
—
|
—
|
33 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
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
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
—
|
—
|
4 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
13 Participants
n=24 Participants
|
—
|
—
|
46 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
—
|
—
|
19 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White · White
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
16 Participants
n=24 Participants
|
—
|
—
|
51 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White · Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
11 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
|
—
|
—
|
12 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White · Other
|
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
|
1 Participants
n=24 Participants
|
—
|
—
|
2 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White · Missing
|
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
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
—
|
—
|
4 Participants
n=42 Participants
|
|
ECOG Performance Status
0
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
—
|
—
|
24 Participants
n=42 Participants
|
|
ECOG Performance Status
1
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
—
|
—
|
32 Participants
n=42 Participants
|
|
ECOG Performance Status
2
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
—
|
—
|
13 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: Dose Determining Set. Dose was not escalated to enroll participants in Stratum-2 : Cohorts 4 and 5.
DLT was defined as the occurrence of any of the following treatment-related toxicities, occurring through Day 28: Any grade ≥ 2 hemorrhagic event ; Any grade thrombocytopenia requiring PLT transfusion; PLT count \< 25x109/L\*; Grade 4 neutropenia (absolute neutrophil count \< 0.5x109/L)\*; Grade ≥ 3 febrile neutropenia\*; Grade ≥ 2 total serum bilirubin with coincident direct bilirubin ≥ 0.5 mg/dL; Grade 3 non-hematologic toxicity for ≥ 7 consecutive days; Grade 4 non-hematologic toxicity. In the dose escalation stage in the core study period, the starting does in both strata was 5mg bid. Successive cohorts of newly enrolled patients received increasing doses of ruxolitinib until the Maximum Safe Starting Dose (MSSD) was determined. Initially, only patients with PLT counts 75-99 x10\^9/L (stratum 1) were allowed to be enrolled. Once safety was established in stratum 1 at the first 2 dose cohorts, eligible population was further expanded to patients with PLT counts 50-74 x10\^9/L (stratum 2).
Outcome measures
| Measure |
Stratum 1 : Cohort 1
n=5 Participants
Ruxolitinib was administered at 5 mg bid
|
Stratum 1 : Cohort 2
n=3 Participants
Ruxolitinib was administered at 5 mg q.AM+ 10 mg q.PM
|
Stratum 1 : Cohort 3
n=3 Participants
Ruxolitinib was administered at a starting dose of 10 mg q.AM + 10 mg q.PM
|
Stratum 1 : Cohort 4
n=3 Participants
Ruxolitinib was administered at a starting dose of 10 mg q.AM + 15 mg q.PM
|
Stratum 1 : Cohort 5
n=12 Participants
Ruxolitinib was administered at a starting dose of 15 mg q.AM + 15 mg q.PM
|
Stratum 2 : Cohort 1
n=3 Participants
Ruxolitinib was administered at 5 mg q.AM + 5 mg q.PM
|
Stratum 2 : Cohort 2
n=4 Participants
Ruxolitinib was administered at 5 mg q.AM+ 10 mg q.PM
|
Stratum 2 : Cohort 3
n=12 Participants
Ruxolitinib was administered at 10 mg q.AM+ 10 mg q.PM
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: approximately 4 yearsPopulation: Full Analysis Population; Multiple dose cohorts within the strata are combined based on the total dose levels as specified in Statistical Analysis Plan
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Outcome measures
| Measure |
Stratum 1 : Cohort 1
n=8 Participants
Ruxolitinib was administered at 5 mg bid
|
Stratum 1 : Cohort 2
n=20 Participants
Ruxolitinib was administered at 5 mg q.AM+ 10 mg q.PM
|
Stratum 1 : Cohort 3
n=16 Participants
Ruxolitinib was administered at a starting dose of 10 mg q.AM + 10 mg q.PM
|
Stratum 1 : Cohort 4
n=7 Participants
Ruxolitinib was administered at a starting dose of 10 mg q.AM + 15 mg q.PM
|
Stratum 1 : Cohort 5
n=18 Participants
Ruxolitinib was administered at a starting dose of 15 mg q.AM + 15 mg q.PM
|
Stratum 2 : Cohort 1
Ruxolitinib was administered at 5 mg q.AM + 5 mg q.PM
|
Stratum 2 : Cohort 2
Ruxolitinib was administered at 5 mg q.AM+ 10 mg q.PM
|
Stratum 2 : Cohort 3
Ruxolitinib was administered at 10 mg q.AM+ 10 mg q.PM
|
|---|---|---|---|---|---|---|---|---|
|
Number of Treatment Emergent Adverse Events (TEAE's)
|
8 Participants
|
20 Participants
|
16 Participants
|
7 Participants
|
18 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: All participants who had spleen assessment at week 24. Multiple dose cohorts within the strata are grouped according to total daily dose ranges as specified in Statistical Analysis Plan.
Participants achieving ≥ 50% reduction in palpable spleen length relative to study day 1 by treatment and stratum
Outcome measures
| Measure |
Stratum 1 : Cohort 1
n=5 Participants
Ruxolitinib was administered at 5 mg bid
|
Stratum 1 : Cohort 2
n=15 Participants
Ruxolitinib was administered at 5 mg q.AM+ 10 mg q.PM
|
Stratum 1 : Cohort 3
n=13 Participants
Ruxolitinib was administered at a starting dose of 10 mg q.AM + 10 mg q.PM
|
Stratum 1 : Cohort 4
n=5 Participants
Ruxolitinib was administered at a starting dose of 10 mg q.AM + 15 mg q.PM
|
Stratum 1 : Cohort 5
n=8 Participants
Ruxolitinib was administered at a starting dose of 15 mg q.AM + 15 mg q.PM
|
Stratum 2 : Cohort 1
Ruxolitinib was administered at 5 mg q.AM + 5 mg q.PM
|
Stratum 2 : Cohort 2
Ruxolitinib was administered at 5 mg q.AM+ 10 mg q.PM
|
Stratum 2 : Cohort 3
Ruxolitinib was administered at 10 mg q.AM+ 10 mg q.PM
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Achieving ≥ 50% Reduction in Palpable Spleen Length
|
3 Participants
|
6 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 168, 252, 336, 420, 504, 588, 672, 756, 1008, 1092Population: Change in spleen length measurement as compared to baseline are summarized by time and by stratum as specified in the SAP.
Defined as measurement of change in spleen length by palpation from baseline
Outcome measures
| Measure |
Stratum 1 : Cohort 1
n=44 Participants
Ruxolitinib was administered at 5 mg bid
|
Stratum 1 : Cohort 2
n=25 Participants
Ruxolitinib was administered at 5 mg q.AM+ 10 mg q.PM
|
Stratum 1 : Cohort 3
Ruxolitinib was administered at a starting dose of 10 mg q.AM + 10 mg q.PM
|
Stratum 1 : Cohort 4
Ruxolitinib was administered at a starting dose of 10 mg q.AM + 15 mg q.PM
|
Stratum 1 : Cohort 5
Ruxolitinib was administered at a starting dose of 15 mg q.AM + 15 mg q.PM
|
Stratum 2 : Cohort 1
Ruxolitinib was administered at 5 mg q.AM + 5 mg q.PM
|
Stratum 2 : Cohort 2
Ruxolitinib was administered at 5 mg q.AM+ 10 mg q.PM
|
Stratum 2 : Cohort 3
Ruxolitinib was administered at 10 mg q.AM+ 10 mg q.PM
|
|---|---|---|---|---|---|---|---|---|
|
Change in Spleen Length as Measure by Palpation Over Time
Day 113
|
-4.7 cm
Standard Deviation 3.29
|
-6.0 cm
Standard Deviation 4.74
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Spleen Length as Measure by Palpation Over Time
Day 8
|
-2.8 cm
Standard Deviation 2.73
|
-3.7 cm
Standard Deviation 2.98
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Spleen Length as Measure by Palpation Over Time
Day 15
|
-3.3 cm
Standard Deviation 2.7
|
-5.4 cm
Standard Deviation 4.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Spleen Length as Measure by Palpation Over Time
Day 22
|
-5.2 cm
Standard Deviation 2.87
|
-5.4 cm
Standard Deviation 4.81
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Spleen Length as Measure by Palpation Over Time
Day 29
|
-4.4 cm
Standard Deviation 3.14
|
-6.0 cm
Standard Deviation 4.23
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Spleen Length as Measure by Palpation Over Time
Day 43
|
-4.6 cm
Standard Deviation 2.74
|
-5.8 cm
Standard Deviation 4.31
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Spleen Length as Measure by Palpation Over Time
Day 57
|
-4.5 cm
Standard Deviation 2.98
|
-5.6 cm
Standard Deviation 4.52
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Spleen Length as Measure by Palpation Over Time
Day 85
|
-4.5 cm
Standard Deviation 3.53
|
-5.2 cm
Standard Deviation 4.32
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Spleen Length as Measure by Palpation Over Time
Day 141
|
-4.9 cm
Standard Deviation 3.24
|
-6.7 cm
Standard Deviation 4.43
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Spleen Length as Measure by Palpation Over Time
Day 168
|
-5.2 cm
Standard Deviation 3.73
|
-5.0 cm
Standard Deviation 4.78
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Spleen Length as Measure by Palpation Over Time
Day 252
|
-5.5 cm
Standard Deviation 4.40
|
-3.6 cm
Standard Deviation 6.67
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Spleen Length as Measure by Palpation Over Time
Day 336
|
-5.1 cm
Standard Deviation 4.64
|
-5.3 cm
Standard Deviation 4.86
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Spleen Length as Measure by Palpation Over Time
Day 420
|
-6.1 cm
Standard Deviation 4.80
|
-4.9 cm
Standard Deviation 5.75
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Spleen Length as Measure by Palpation Over Time
Day 504
|
-5.7 cm
Standard Deviation 4.0
|
-4.9 cm
Standard Deviation 4.91
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Spleen Length as Measure by Palpation Over Time
Day 588
|
-4.7 cm
Standard Deviation 5.24
|
-5.4 cm
Standard Deviation 5.61
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Spleen Length as Measure by Palpation Over Time
Day 672
|
-5.8 cm
Standard Deviation 5.33
|
-4.4 cm
Standard Deviation 6.60
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Spleen Length as Measure by Palpation Over Time
Day 756
|
-5.7 cm
Standard Deviation 5.22
|
-6.0 cm
Standard Deviation 6.03
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Spleen Length as Measure by Palpation Over Time
Day 1008
|
-7.6 cm
Standard Deviation 3.93
|
-8.0 cm
Standard Deviation 4.55
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Spleen Length as Measure by Palpation Over Time
Day 1092
|
-6.8 cm
Standard Deviation 1.71
|
-4.2 cm
Standard Deviation 5.81
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Results are summarized by strata, as dose relationship is accounted for by PK quartiles.
To define the PK and C Reactive Protein relationship using PK Quartiles (AUC 0-12, ng\*h/mL)
Outcome measures
| Measure |
Stratum 1 : Cohort 1
n=44 Participants
Ruxolitinib was administered at 5 mg bid
|
Stratum 1 : Cohort 2
n=25 Participants
Ruxolitinib was administered at 5 mg q.AM+ 10 mg q.PM
|
Stratum 1 : Cohort 3
Ruxolitinib was administered at a starting dose of 10 mg q.AM + 10 mg q.PM
|
Stratum 1 : Cohort 4
Ruxolitinib was administered at a starting dose of 10 mg q.AM + 15 mg q.PM
|
Stratum 1 : Cohort 5
Ruxolitinib was administered at a starting dose of 15 mg q.AM + 15 mg q.PM
|
Stratum 2 : Cohort 1
Ruxolitinib was administered at 5 mg q.AM + 5 mg q.PM
|
Stratum 2 : Cohort 2
Ruxolitinib was administered at 5 mg q.AM+ 10 mg q.PM
|
Stratum 2 : Cohort 3
Ruxolitinib was administered at 10 mg q.AM+ 10 mg q.PM
|
|---|---|---|---|---|---|---|---|---|
|
PK- C Reactive Protein Levels by PK Quartile (AUC0-12)
Quartile 4 Day 1
|
0.96 micrograms/mL
Standard Deviation 1.05
|
5.4 micrograms/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK- C Reactive Protein Levels by PK Quartile (AUC0-12)
Quartile 1 Day 1
|
14 micrograms/mL
Standard Deviation 5.73
|
12 micrograms/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK- C Reactive Protein Levels by PK Quartile (AUC0-12)
Quartile 1 Day 29
|
21.2 micrograms/mL
Standard Deviation 31.5
|
2.6 micrograms/mL
Standard Deviation 2.05
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK- C Reactive Protein Levels by PK Quartile (AUC0-12)
Quartile 1 Day 168
|
7.6 micrograms/mL
Standard Deviation 8
|
5.51 micrograms/mL
Standard Deviation 4.98
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK- C Reactive Protein Levels by PK Quartile (AUC0-12)
Quartile 2 Day 1
|
9.5 micrograms/mL
Standard Deviation 0.707
|
7.7 micrograms/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK- C Reactive Protein Levels by PK Quartile (AUC0-12)
Quartile 2 Day 29
|
10.2 micrograms/mL
Standard Deviation 23.8
|
1.84 micrograms/mL
Standard Deviation 173
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK- C Reactive Protein Levels by PK Quartile (AUC0-12)
Quartile 2 Day 168
|
8.37 micrograms/mL
Standard Deviation 12.8
|
2.41 micrograms/mL
Standard Deviation 1.45
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK- C Reactive Protein Levels by PK Quartile (AUC0-12)
Quartile 3 Day 1
|
6.85 micrograms/mL
Standard Deviation 7.28
|
6.5 micrograms/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK- C Reactive Protein Levels by PK Quartile (AUC0-12)
Quartile 3 Day 29
|
2.76 micrograms/mL
Standard Deviation 4.66
|
7.36 micrograms/mL
Standard Deviation 9.06
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK- C Reactive Protein Levels by PK Quartile (AUC0-12)
Quartile 3 Day 168
|
7.7 micrograms/mL
Standard Deviation 14.9
|
4.98 micrograms/mL
Standard Deviation 5.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK- C Reactive Protein Levels by PK Quartile (AUC0-12)
Quartile 4 Day 29
|
1.87 micrograms/mL
Standard Deviation 1.43
|
12.4 micrograms/mL
Standard Deviation 17.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK- C Reactive Protein Levels by PK Quartile (AUC0-12)
Quartile 4 Day 168
|
4.88 micrograms/mL
Standard Deviation 9.01
|
4.9 micrograms/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Results are summarized by strata, as dose relationship is accounted for by PK quartiles.
To define the PK and Interleukin 1 Receptor Antagonist relationship relationship using PK Quartiles (AUC 0-12, ng\*h/mL)
Outcome measures
| Measure |
Stratum 1 : Cohort 1
n=44 Participants
Ruxolitinib was administered at 5 mg bid
|
Stratum 1 : Cohort 2
n=25 Participants
Ruxolitinib was administered at 5 mg q.AM+ 10 mg q.PM
|
Stratum 1 : Cohort 3
Ruxolitinib was administered at a starting dose of 10 mg q.AM + 10 mg q.PM
|
Stratum 1 : Cohort 4
Ruxolitinib was administered at a starting dose of 10 mg q.AM + 15 mg q.PM
|
Stratum 1 : Cohort 5
Ruxolitinib was administered at a starting dose of 15 mg q.AM + 15 mg q.PM
|
Stratum 2 : Cohort 1
Ruxolitinib was administered at 5 mg q.AM + 5 mg q.PM
|
Stratum 2 : Cohort 2
Ruxolitinib was administered at 5 mg q.AM+ 10 mg q.PM
|
Stratum 2 : Cohort 3
Ruxolitinib was administered at 10 mg q.AM+ 10 mg q.PM
|
|---|---|---|---|---|---|---|---|---|
|
PK- Interleukin 1 Receptor Antagonist Levels by PK Quartile (AUC0-12)
Quartile 1 Day 1
|
188 picograms/mL
Standard Deviation 116
|
105 picograms/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK- Interleukin 1 Receptor Antagonist Levels by PK Quartile (AUC0-12)
Quartile 1 Day 29
|
267 picograms/mL
Standard Deviation 334
|
588 picograms/mL
Standard Deviation 730
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK- Interleukin 1 Receptor Antagonist Levels by PK Quartile (AUC0-12)
Quartile 1 Day 168
|
592 picograms/mL
Standard Deviation 532
|
379 picograms/mL
Standard Deviation 419
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK- Interleukin 1 Receptor Antagonist Levels by PK Quartile (AUC0-12)
Quartile 2 Day 1
|
179 picograms/mL
Standard Deviation 43.1
|
133 picograms/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK- Interleukin 1 Receptor Antagonist Levels by PK Quartile (AUC0-12)
Quartile 2 Day 29
|
524 picograms/mL
Standard Deviation 519
|
600 picograms/mL
Standard Deviation 649
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK- Interleukin 1 Receptor Antagonist Levels by PK Quartile (AUC0-12)
Quartile 2 Day 168
|
557 picograms/mL
Standard Deviation 504
|
334 picograms/mL
Standard Deviation 322
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK- Interleukin 1 Receptor Antagonist Levels by PK Quartile (AUC0-12)
Quartile 3 Day 1
|
319 picograms/mL
Standard Deviation 288
|
191 picograms/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK- Interleukin 1 Receptor Antagonist Levels by PK Quartile (AUC0-12)
Quartile 3 Day 29
|
304 picograms/mL
Standard Deviation 327
|
452 picograms/mL
Standard Deviation 529
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK- Interleukin 1 Receptor Antagonist Levels by PK Quartile (AUC0-12)
Quartile 3 Day 168
|
549 picograms/mL
Standard Deviation 531
|
960 picograms/mL
Standard Deviation 792
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK- Interleukin 1 Receptor Antagonist Levels by PK Quartile (AUC0-12)
Quartile 4 Day 1
|
120 picograms/mL
Standard Deviation 40.3
|
148 picograms/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK- Interleukin 1 Receptor Antagonist Levels by PK Quartile (AUC0-12)
Quartile 4 Day 29
|
604 picograms/mL
Standard Deviation 647
|
475 picograms/mL
Standard Deviation 464
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK- Interleukin 1 Receptor Antagonist Levels by PK Quartile (AUC0-12)
Quartile 4 Day 168
|
562 picograms/mL
Standard Deviation 758
|
378 picograms/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Results are summarized by strata, as dose relationship is accounted for by PK quartiles.
To define the PK and Tissue Necrosis Factor Receptor 2 relationship using PK Quartiles (AUC 0-12, ng\*h/mL)
Outcome measures
| Measure |
Stratum 1 : Cohort 1
n=44 Participants
Ruxolitinib was administered at 5 mg bid
|
Stratum 1 : Cohort 2
n=25 Participants
Ruxolitinib was administered at 5 mg q.AM+ 10 mg q.PM
|
Stratum 1 : Cohort 3
Ruxolitinib was administered at a starting dose of 10 mg q.AM + 10 mg q.PM
|
Stratum 1 : Cohort 4
Ruxolitinib was administered at a starting dose of 10 mg q.AM + 15 mg q.PM
|
Stratum 1 : Cohort 5
Ruxolitinib was administered at a starting dose of 15 mg q.AM + 15 mg q.PM
|
Stratum 2 : Cohort 1
Ruxolitinib was administered at 5 mg q.AM + 5 mg q.PM
|
Stratum 2 : Cohort 2
Ruxolitinib was administered at 5 mg q.AM+ 10 mg q.PM
|
Stratum 2 : Cohort 3
Ruxolitinib was administered at 10 mg q.AM+ 10 mg q.PM
|
|---|---|---|---|---|---|---|---|---|
|
PK- Tissue Necrosis Factor Receptor 2 Levels by PK Quartile (AUC0-12)
Quartile 1 Day 1
|
24 nanograms/mL
Standard Deviation 19.8
|
6.2 nanograms/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK- Tissue Necrosis Factor Receptor 2 Levels by PK Quartile (AUC0-12)
Quartile 1 Day 29
|
20.5 nanograms/mL
Standard Deviation 19.7
|
25.7 nanograms/mL
Standard Deviation 14.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK- Tissue Necrosis Factor Receptor 2 Levels by PK Quartile (AUC0-12)
Quartile 1 Day 168
|
14 nanograms/mL
Standard Deviation 4.24
|
22.6 nanograms/mL
Standard Deviation 12.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK- Tissue Necrosis Factor Receptor 2 Levels by PK Quartile (AUC0-12)
Quartile 2 Day 1
|
13.5 nanograms/mL
Standard Deviation 0.707
|
8.2 nanograms/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK- Tissue Necrosis Factor Receptor 2 Levels by PK Quartile (AUC0-12)
Quartile 2 Day 29
|
14.9 nanograms/mL
Standard Deviation 6.62
|
12.3 nanograms/mL
Standard Deviation 7.67
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK- Tissue Necrosis Factor Receptor 2 Levels by PK Quartile (AUC0-12)
Quartile 2 Day 168
|
36.1 nanograms/mL
Standard Deviation 22.9
|
18.4 nanograms/mL
Standard Deviation 12.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK- Tissue Necrosis Factor Receptor 2 Levels by PK Quartile (AUC0-12)
Quartile 3 Day 1
|
21 nanograms/mL
Standard Deviation 9.9
|
47 nanograms/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK- Tissue Necrosis Factor Receptor 2 Levels by PK Quartile (AUC0-12)
Quartile 3 Day 29
|
12.9 nanograms/mL
Standard Deviation 4.32
|
13.7 nanograms/mL
Standard Deviation 11.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK- Tissue Necrosis Factor Receptor 2 Levels by PK Quartile (AUC0-12)
Quartile 3 Day 168
|
13.3 nanograms/mL
Standard Deviation 5.8
|
12.4 nanograms/mL
Standard Deviation 7.99
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK- Tissue Necrosis Factor Receptor 2 Levels by PK Quartile (AUC0-12)
Quartile 4 Day 1
|
15 nanograms/mL
Standard Deviation 4.24
|
24 nanograms/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK- Tissue Necrosis Factor Receptor 2 Levels by PK Quartile (AUC0-12)
Quartile 4 Day 29
|
15.7 nanograms/mL
Standard Deviation 9.13
|
24.6 nanograms/mL
Standard Deviation 17.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK- Tissue Necrosis Factor Receptor 2 Levels by PK Quartile (AUC0-12)
Quartile 4 Day 168
|
14.3 nanograms/mL
Standard Deviation 7.67
|
11 nanograms/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0.25 to 0.75, 1 to 3, and 4 to 12 hours postdose on Day 1 and predose, 0.25 to 0.75 hours, and 1 to 3 hours postdose on Day 15, with a random sample on Days 29 and 57Population: Results are summarized by strata; dose relationship is accounted for by PK quartile grouping.
Area Under the Serum Concentration Versus Time Curve，Time 0 to Infinity
Outcome measures
| Measure |
Stratum 1 : Cohort 1
n=15 Participants
Ruxolitinib was administered at 5 mg bid
|
Stratum 1 : Cohort 2
n=16 Participants
Ruxolitinib was administered at 5 mg q.AM+ 10 mg q.PM
|
Stratum 1 : Cohort 3
n=9 Participants
Ruxolitinib was administered at a starting dose of 10 mg q.AM + 10 mg q.PM
|
Stratum 1 : Cohort 4
Ruxolitinib was administered at a starting dose of 10 mg q.AM + 15 mg q.PM
|
Stratum 1 : Cohort 5
Ruxolitinib was administered at a starting dose of 15 mg q.AM + 15 mg q.PM
|
Stratum 2 : Cohort 1
Ruxolitinib was administered at 5 mg q.AM + 5 mg q.PM
|
Stratum 2 : Cohort 2
Ruxolitinib was administered at 5 mg q.AM+ 10 mg q.PM
|
Stratum 2 : Cohort 3
Ruxolitinib was administered at 10 mg q.AM+ 10 mg q.PM
|
|---|---|---|---|---|---|---|---|---|
|
AUC 0-Inf
|
1027 nM*hr
Standard Deviation 357
|
1930 nM*hr
Standard Deviation 562
|
3756 nM*hr
Standard Deviation 916
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Stratum 1 : Cohort 1
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Stratum 1 : Cohort 2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Stratum 1 : Cohort 3
Serious events: 10 serious events
Other events: 20 other events
Deaths: 3 deaths
Stratum 1 : Cohort 4
Serious events: 4 serious events
Other events: 4 other events
Deaths: 1 deaths
Stratum 1 : Cohort 5
Serious events: 5 serious events
Other events: 12 other events
Deaths: 0 deaths
Stratum 2 : Cohort 1
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Stratum 2 : Cohort 2
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Stratum 2 : Cohort 3
Serious events: 9 serious events
Other events: 18 other events
Deaths: 4 deaths
Stratum 2 : Cohort 4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stratum 2 : Cohort 5
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stratum 1 : Cohort 1
n=5 participants at risk
Ruxolitinib was administered at 5 mg bid in Participants with baseline Platelet counts of 75-99x10\^9/L
|
Stratum 1 : Cohort 2
n=3 participants at risk
Ruxolitinib was administered at 5 mg q.AM / 10 mg q.PM in Participants with baseline Platelet counts of 75-99 x10\^9/L
|
Stratum 1 : Cohort 3
n=20 participants at risk
Ruxolitinib was administered to cohort 3 at 10 mg bid in Participants with baseline Platelet counts of 75-99 x10\^9/L
|
Stratum 1 : Cohort 4
n=4 participants at risk
Ruxolitinib was administered at 10 mg q.AM / 15 mg q.PM) in Participants with baseline Platelet counts of 75-99 x10\^9/L
|
Stratum 1 : Cohort 5
n=12 participants at risk
Ruxolitinib was administered at 15 mg bid in Participants with baseline Platelet counts of 75-99 x10\^9/L
|
Stratum 2 : Cohort 1
n=3 participants at risk
Ruxolitinib was administered at 5 mg bid in participants with baseline Platelet counts of 50-74x10\^9/L
|
Stratum 2 : Cohort 2
n=4 participants at risk
Ruxolitinib was administered at 5 mg q.AM / 10 mg q.PM) in participants with baseline Platelet counts of 50-74 x10\^9/L
|
Stratum 2 : Cohort 3
n=18 participants at risk
Ruxolitinib was administered at 10 mg bid in participants with baseline Platelet counts of 50-74 x10\^9/L
|
Stratum 2 : Cohort 4
Ruxolitinib was administered at 10 mg q.AM / 15 mg q.PM in participants with baseline Platelet counts of 50-74 x10\^9/L
|
Stratum 2 : Cohort 5
Ruxolitinib was administered at 15 mg bid in participants with baseline Platelet counts of 50-74 x10\^9/L
|
|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Sudden death
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
1/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Blood and lymphatic system disorders
Splenomegaly
|
20.0%
1/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
11.1%
2/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
General disorders
Asthenia
|
20.0%
1/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
General disorders
Fatigue
|
20.0%
1/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
General disorders
General physical health deterioration
|
20.0%
1/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
General disorders
Oedema peripheral
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
General disorders
Pyrexia
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
0.00%
0/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Appendicitis
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Pneumonia
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
11.1%
2/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
1/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chloroma
|
20.0%
1/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelofibrosis
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Nervous system disorders
IIIrd nerve paralysis
|
20.0%
1/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Nervous system disorders
Neuralgia
|
20.0%
1/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Nervous system disorders
Syncope
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
10.0%
2/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
16.7%
2/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Vascular disorders
Bleeding varicose vein
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Vascular disorders
Haematoma
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Blood and lymphatic system disorders
Leukopenia
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Cardiac disorders
Atrial fibrillation
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Cardiac disorders
Cardiac failure
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Cardiac disorders
Right ventricular failure
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Gastrointestinal disorders
Ascites
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Gastrointestinal disorders
Gastric ulcer
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Gastrointestinal disorders
Intestinal obstruction
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
General disorders
Multiple organ dysfunction syndrome
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Bronchitis
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Disseminated tuberculosis
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Influenza
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Sepsis
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
11.1%
2/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transformation to acute myeloid leukaemia
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Nervous system disorders
Presyncope
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Vascular disorders
Peripheral artery occlusion
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
Other adverse events
| Measure |
Stratum 1 : Cohort 1
n=5 participants at risk
Ruxolitinib was administered at 5 mg bid in Participants with baseline Platelet counts of 75-99x10\^9/L
|
Stratum 1 : Cohort 2
n=3 participants at risk
Ruxolitinib was administered at 5 mg q.AM / 10 mg q.PM in Participants with baseline Platelet counts of 75-99 x10\^9/L
|
Stratum 1 : Cohort 3
n=20 participants at risk
Ruxolitinib was administered to cohort 3 at 10 mg bid in Participants with baseline Platelet counts of 75-99 x10\^9/L
|
Stratum 1 : Cohort 4
n=4 participants at risk
Ruxolitinib was administered at 10 mg q.AM / 15 mg q.PM) in Participants with baseline Platelet counts of 75-99 x10\^9/L
|
Stratum 1 : Cohort 5
n=12 participants at risk
Ruxolitinib was administered at 15 mg bid in Participants with baseline Platelet counts of 75-99 x10\^9/L
|
Stratum 2 : Cohort 1
n=3 participants at risk
Ruxolitinib was administered at 5 mg bid in participants with baseline Platelet counts of 50-74x10\^9/L
|
Stratum 2 : Cohort 2
n=4 participants at risk
Ruxolitinib was administered at 5 mg q.AM / 10 mg q.PM) in participants with baseline Platelet counts of 50-74 x10\^9/L
|
Stratum 2 : Cohort 3
n=18 participants at risk
Ruxolitinib was administered at 10 mg bid in participants with baseline Platelet counts of 50-74 x10\^9/L
|
Stratum 2 : Cohort 4
Ruxolitinib was administered at 10 mg q.AM / 15 mg q.PM in participants with baseline Platelet counts of 50-74 x10\^9/L
|
Stratum 2 : Cohort 5
Ruxolitinib was administered at 15 mg bid in participants with baseline Platelet counts of 50-74 x10\^9/L
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
60.0%
3/5 • Up to 4 years
AE additional description
|
66.7%
2/3 • Up to 4 years
AE additional description
|
55.0%
11/20 • Up to 4 years
AE additional description
|
50.0%
2/4 • Up to 4 years
AE additional description
|
50.0%
6/12 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
75.0%
3/4 • Up to 4 years
AE additional description
|
44.4%
8/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Blood and lymphatic system disorders
Haemorrhagic diathesis
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
10.0%
2/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.0%
1/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
80.0%
4/5 • Up to 4 years
AE additional description
|
66.7%
2/3 • Up to 4 years
AE additional description
|
45.0%
9/20 • Up to 4 years
AE additional description
|
75.0%
3/4 • Up to 4 years
AE additional description
|
91.7%
11/12 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
100.0%
4/4 • Up to 4 years
AE additional description
|
77.8%
14/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Cardiac disorders
Pericardial effusion
|
20.0%
1/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Cardiac disorders
Tachycardia
|
20.0%
1/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Eye disorders
Cataract
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Eye disorders
Dry eye
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Eye disorders
Uveitis
|
0.00%
0/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
11.1%
2/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
25.0%
5/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
16.7%
2/12 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
22.2%
4/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Gastrointestinal disorders
Abdominal pain upper
|
20.0%
1/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
10.0%
2/20 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
16.7%
2/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
50.0%
2/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
2/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
30.0%
6/20 • Up to 4 years
AE additional description
|
50.0%
2/4 • Up to 4 years
AE additional description
|
25.0%
3/12 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
50.0%
2/4 • Up to 4 years
AE additional description
|
27.8%
5/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Gastrointestinal disorders
Dyspepsia
|
20.0%
1/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Gastrointestinal disorders
Gingival pain
|
20.0%
1/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Gastrointestinal disorders
Intestinal dilatation
|
0.00%
0/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
22.2%
4/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
16.7%
2/12 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Gastrointestinal disorders
Toothache
|
20.0%
1/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
15.0%
3/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
16.7%
3/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
General disorders
Asthenia
|
40.0%
2/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
15.0%
3/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
16.7%
2/12 • Up to 4 years
AE additional description
|
66.7%
2/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
27.8%
5/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
General disorders
Chest pain
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
General disorders
Fatigue
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
15.0%
3/20 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
25.0%
3/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
16.7%
3/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
General disorders
Feeling cold
|
0.00%
0/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
General disorders
Hernia pain
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
General disorders
Influenza like illness
|
20.0%
1/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
General disorders
Oedema peripheral
|
0.00%
0/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
50.0%
2/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
16.7%
3/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
General disorders
Pain
|
0.00%
0/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
General disorders
Pyrexia
|
20.0%
1/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
30.0%
6/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
16.7%
2/12 • Up to 4 years
AE additional description
|
66.7%
2/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
22.2%
4/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
General disorders
Swelling face
|
20.0%
1/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
10.0%
2/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Bronchitis
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
50.0%
2/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
10.0%
2/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Gastroenteritis viral
|
20.0%
1/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
10.0%
2/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Genital herpes
|
0.00%
0/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
10.0%
2/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Infection
|
0.00%
0/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
20.0%
4/20 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
27.8%
5/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Oral herpes
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
16.7%
2/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Oral infection
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
10.0%
2/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Rhinitis
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Tooth infection
|
20.0%
1/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
15.0%
3/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
11.1%
2/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Urinary tract infection
|
20.0%
1/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
10.0%
2/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
11.1%
2/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Varicella zoster virus infection
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
10.0%
2/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
50.0%
2/4 • Up to 4 years
AE additional description
|
11.1%
2/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Injury, poisoning and procedural complications
Procedural pain
|
40.0%
2/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
15.0%
3/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
15.0%
3/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
11.1%
2/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
20.0%
4/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Investigations
Blood creatinine increased
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
16.7%
2/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Investigations
Blood fibrinogen decreased
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Investigations
Blood uric acid increased
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Investigations
Coagulation factor V level decreased
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Investigations
Coagulation factor VII level decreased
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Investigations
Coagulation factor X level decreased
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
11.1%
2/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
20.0%
4/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
10.0%
2/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Investigations
Mean cell volume increased
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
15.0%
3/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Investigations
Platelet count decreased
|
0.00%
0/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
30.0%
6/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Investigations
Prothrombin level decreased
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Investigations
Prothrombin time shortened
|
20.0%
1/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
10.0%
2/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Investigations
Weight increased
|
0.00%
0/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Investigations
White blood cell count decreased
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
5/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
1/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
11.1%
2/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
10.0%
2/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
66.7%
2/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
11.1%
2/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
10.0%
2/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
27.8%
5/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
10.0%
2/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
1/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
10.0%
2/20 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
11.1%
2/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
20.0%
4/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
66.7%
2/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
16.7%
3/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
20.0%
1/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
16.7%
2/12 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
11.1%
2/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
11.1%
2/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
20.0%
1/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
20.0%
1/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
20.0%
1/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
1/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
25.0%
3/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
75.0%
3/4 • Up to 4 years
AE additional description
|
16.7%
3/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
20.0%
1/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Nervous system disorders
Dizziness
|
40.0%
2/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
10.0%
2/20 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Nervous system disorders
Headache
|
40.0%
2/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
25.0%
3/12 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
22.2%
4/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Psychiatric disorders
Insomnia
|
60.0%
3/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Psychiatric disorders
Nervousness
|
20.0%
1/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Renal and urinary disorders
Bladder pain
|
20.0%
1/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Renal and urinary disorders
Micturition urgency
|
20.0%
1/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Renal and urinary disorders
Pollakiuria
|
20.0%
1/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Renal and urinary disorders
Renal pain
|
20.0%
1/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
10.0%
2/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
25.0%
3/12 • Up to 4 years
AE additional description
|
66.7%
2/3 • Up to 4 years
AE additional description
|
50.0%
2/4 • Up to 4 years
AE additional description
|
33.3%
6/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
10.0%
2/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
11.1%
2/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
11.1%
2/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
40.0%
2/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
5/20 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
16.7%
2/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
20.0%
1/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
10.0%
2/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
11.1%
2/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/5 • Up to 4 years
AE additional description
|
66.7%
2/3 • Up to 4 years
AE additional description
|
30.0%
6/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
11.1%
2/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
10.0%
2/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
11.1%
2/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
15.0%
3/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
50.0%
2/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/5 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Vascular disorders
Haematoma
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
11.1%
2/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
5.0%
1/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
22.2%
4/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/5 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/20 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
8.3%
1/12 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Blood and lymphatic system disorders
Leukocytosis
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
16.7%
3/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Blood and lymphatic system disorders
Platelet aggregation inhibition
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Cardiac disorders
Diastolic dysfunction
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Cardiac disorders
Extrasystoles
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Cardiac disorders
Sinus bradycardia
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Cardiac disorders
Tricuspid valve disease
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Ear and labyrinth disorders
Tinnitus
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Ear and labyrinth disorders
Vertigo
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Eye disorders
Eye haemorrhage
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Eye disorders
Vision blurred
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Gastrointestinal disorders
Abdominal discomfort
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Gastrointestinal disorders
Aphthous ulcer
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Gastrointestinal disorders
Dental caries
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Gastrointestinal disorders
Dieulafoy's vascular malformation
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Gastrointestinal disorders
Mouth ulceration
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Gastrointestinal disorders
Oral disorder
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Gastrointestinal disorders
Stomatitis
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
General disorders
Chills
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
General disorders
Malaise
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
General disorders
Mucosal inflammation
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
General disorders
Oedema
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
General disorders
Xerosis
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Hepatobiliary disorders
Jaundice
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Campylobacter infection
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Cystitis
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Escherichia urinary tract infection
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Folliculitis
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Herpes simplex
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Herpes zoster
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Influenza
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
11.1%
2/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Oropharyngeal candidiasis
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Periodontitis
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Pharyngitis
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Pharyngotonsillitis
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Pneumonia
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Infections and infestations
Vulvovaginal candidiasis
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Injury, poisoning and procedural complications
Head injury
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Injury, poisoning and procedural complications
Scratch
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Injury, poisoning and procedural complications
Wound
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Investigations
Amylase increased
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Investigations
Blood calcium decreased
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Investigations
Blood lactate dehydrogenase increased
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Investigations
Blood urea increased
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Investigations
Cardiac murmur
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Investigations
Lipase increased
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Investigations
Urine output increased
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Investigations
White blood cell count increased
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Metabolism and nutrition disorders
Gout
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Metabolism and nutrition disorders
Iron overload
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
11.1%
2/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Nervous system disorders
Memory impairment
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
11.1%
2/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Nervous system disorders
Presyncope
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Nervous system disorders
Somnolence
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Nervous system disorders
Tremor
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Psychiatric disorders
Depression
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
11.1%
2/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Renal and urinary disorders
Dysuria
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Renal and urinary disorders
Haematuria
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Renal and urinary disorders
Renal failure
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
33.3%
1/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Skin and subcutaneous tissue disorders
Acne
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Skin and subcutaneous tissue disorders
Rash
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Vascular disorders
Haemorrhage
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Vascular disorders
Hot flush
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Vascular disorders
Pallor
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
11.1%
2/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Vascular disorders
Peripheral ischaemia
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
25.0%
1/4 • Up to 4 years
AE additional description
|
0.00%
0/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
|
Vascular disorders
Systolic hypertension
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
0.00%
0/3 • Up to 4 years
AE additional description
|
0.00%
0/4 • Up to 4 years
AE additional description
|
5.6%
1/18 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
—
0/0 • Up to 4 years
AE additional description
|
Additional Information
Incyte Corporation Call Center, Study Director
Incyte Corporation
Phone: 1-855-463-3463
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Clinical Study Agreement
- Publication restrictions are in place
Restriction type: OTHER