Trial Outcomes & Findings for Multi-Dose Safety/Pharmacodynamic Study of SEL-212/SEL-037 in Subjects With Symptomatic Gout & Elevated Blood Uric Acid (NCT NCT02959918)
NCT ID: NCT02959918
Last Updated: 2022-02-14
Results Overview
To determine the safety and tolerability of SEL-037 (pegadricase) after up to 5 monthly infusions, of SEL-212 for 3 monthly infusions followed by 2 monthly infusions of SEL-037 (pegadricase), or of SEL-212 for 5 monthly infusions as assessed by the percentage of participants in a treatment arm experiencing serious adverse events and percentage of participants experiencing those adverse events that were reported by 5 or more percentage of participants in any arm in the safety analysis set
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
152 participants
Primary outcome timeframe
Five monthly infusions
Results posted on
2022-02-14
Participant Flow
Participant milestones
| Measure |
SEL-037 (Pegadricase) Low Dose
Pegadricase 0.2 mg/kg IV every 28 days for up to 5 doses
|
SEL-037 (Pegadricase) High Dose
Pegadricase 0.4mg/kg IV every 28 days for up to 5 doses
|
SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.125 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.125 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 5 Doses
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses
|
SEL-212: SEL-110 0.15 mg/kg + SEL-037 Low 1 Dose Then SEL-110 0.1 mg/kg + SEL-037 Low for 4 Doses
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 1 dose then SEL-110 (0.1 mg/kg) + Pegadricase 0.2 mg/kg every 28 days for 4 doses
|
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 5 Doses
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
9
|
10
|
6
|
11
|
11
|
12
|
14
|
13
|
14
|
23
|
11
|
12
|
|
Overall Study
COMPLETED
|
0
|
0
|
1
|
1
|
1
|
5
|
6
|
6
|
7
|
7
|
8
|
11
|
4
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
8
|
9
|
5
|
6
|
5
|
6
|
7
|
6
|
6
|
12
|
7
|
6
|
Reasons for withdrawal
| Measure |
SEL-037 (Pegadricase) Low Dose
Pegadricase 0.2 mg/kg IV every 28 days for up to 5 doses
|
SEL-037 (Pegadricase) High Dose
Pegadricase 0.4mg/kg IV every 28 days for up to 5 doses
|
SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.125 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.125 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 5 Doses
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses
|
SEL-212: SEL-110 0.15 mg/kg + SEL-037 Low 1 Dose Then SEL-110 0.1 mg/kg + SEL-037 Low for 4 Doses
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 1 dose then SEL-110 (0.1 mg/kg) + Pegadricase 0.2 mg/kg every 28 days for 4 doses
|
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 5 Doses
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
2
|
0
|
0
|
2
|
2
|
1
|
2
|
1
|
1
|
3
|
2
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
2
|
0
|
0
|
1
|
0
|
1
|
1
|
2
|
3
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
2
|
1
|
0
|
1
|
1
|
0
|
|
Overall Study
Stopping Rule Met
|
1
|
0
|
3
|
4
|
5
|
3
|
2
|
4
|
1
|
1
|
3
|
5
|
2
|
1
|
|
Overall Study
Sponsor Decision, Pause in Clinical Trial
|
1
|
2
|
1
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Subject Hospitalized, out of window for next dosing period
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
PI Discretion due to abnormal Hgb results
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Subject under-dosed with study drug and removed by Sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Multi-Dose Safety/Pharmacodynamic Study of SEL-212/SEL-037 in Subjects With Symptomatic Gout & Elevated Blood Uric Acid
Baseline characteristics by cohort
| Measure |
SEL-037 (Pegadricase) Low Dose
n=3 Participants
Pegardricase 0.2 mg/kg every 28 days for up to 5 doses
|
SEL-037 (Pegadricase) High Dose
n=3 Participants
Pegardricase 0.4 mg/kg every 28 days for up to 5 doses
|
SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
n=9 Participants
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
n=10 Participants
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
n=6 Participants
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
n=11 Participants
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
n=11 Participants
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
n=12 Participants
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.125 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
n=14 Participants
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.125 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
n=13 Participants
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
n=14 Participants
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 5 Doses
n=23 Participants
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses
|
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low for 1 Dose Then SEL-110 0.1 mg/kg + SEL-037 Low 4 Doses
n=11 Participants
SEL-212: Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 1 Dose Then SEL-110 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 4 Doses
|
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 5 Doses
n=12 Participants
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses
|
Total
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
10 Participants
n=3 Participants
|
10 Participants
n=6 Participants
|
8 Participants
n=114 Participants
|
12 Participants
|
12 Participants
n=19 Participants
|
21 Participants
n=4 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=7 Participants
|
126 Participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
1 Participants
|
2 Participants
n=19 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
26 Participants
n=3 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
1 Participants
|
3 Participants
n=19 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
14 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
10 Participants
n=3 Participants
|
10 Participants
n=6 Participants
|
12 Participants
n=114 Participants
|
12 Participants
|
11 Participants
n=19 Participants
|
22 Participants
n=4 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=7 Participants
|
138 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Number Analyzed · American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Number Analyzed · Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Number Analyzed · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Number Analyzed · Black or African American
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
6 Participants
|
4 Participants
n=19 Participants
|
7 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
40 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Number Analyzed · White
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
8 Participants
n=3 Participants
|
8 Participants
n=6 Participants
|
10 Participants
n=114 Participants
|
6 Participants
|
10 Participants
n=19 Participants
|
14 Participants
n=4 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=7 Participants
|
103 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Number Analyzed · Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Five monthly infusionsPopulation: Safety analysis set, dosed subjects
To determine the safety and tolerability of SEL-037 (pegadricase) after up to 5 monthly infusions, of SEL-212 for 3 monthly infusions followed by 2 monthly infusions of SEL-037 (pegadricase), or of SEL-212 for 5 monthly infusions as assessed by the percentage of participants in a treatment arm experiencing serious adverse events and percentage of participants experiencing those adverse events that were reported by 5 or more percentage of participants in any arm in the safety analysis set
Outcome measures
| Measure |
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 5 Doses
n=12 Participants
SEL-212: Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses
|
SEL-037 (Pegadricase) Low Dose
n=3 Participants
Pegadricase 0.2 mg/kg IV every 28 days for up to 5 doses
|
SEL-037 (Pegadricase) High Dose
n=3 Participants
Pegadricase 0.4mg/kg IV every 28 days for up to 5 doses
|
SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
n=9 Participants
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110(0.05 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037(0.4 mg/kg) for 2 Doses
n=10 Participants
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
n=6 Participants
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + SEL-037 (pegadricase) 0.2 mg/kg every 28 days for 3 doses followed by SEL-037 0.2 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
n=11 Participants
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
n=11 Participants
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
n=12 Participants
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.125 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
n=14 Participants
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.125 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
n=13 Participants
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
n=14 Participants
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 5 Doses
n=23 Participants
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses
|
SEL-212: SEL-110 0.15 mg/kg + SEL-037 Low Dose x 1 Then SEL-110 0.1 mg/kg + SEL-037 Low x 4 Doses
n=11 Participants
SEL-212: Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg x 1 Then SEL-110 0.1 mg/kg + Pegadricase 0.2 mg/kg x 4 Doses
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability of Multiple Intravenous Infusions of SEL-037 or SEL-212 as Assessed by the Percentage of Participants Experiencing Serious Adverse Events and Those Adverse Events Reported by 5 Percentage or More in the Safety Analysis Set
|
12 Participants
|
3 Participants
|
3 Participants
|
9 Participants
|
10 Participants
|
6 Participants
|
11 Participants
|
11 Participants
|
12 Participants
|
14 Participants
|
13 Participants
|
14 Participants
|
23 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 3 and 5 monthsPopulation: Eligible subjects are those who received the entire first dose, did not discontinue due to withdrawal of consent (during TP 1-4), a protocol deviation (during TP1-2) or a non-study drug-related SAE (during TP1-2). The outcome data is presented with arms combined by regimen (i.e. SEL-037 alone; SEL-212 for 3 doses \& SEL-037 for 2 doses; or SEL-212 for 5 doses) rather than by dosing arm as the outcome is most effected by the SEL-212 combination which results in suppression of anti-drug antibodies.
Measurement of the number of participants with reduced serum uric acid after multiple monthly infusions with or without SEL-110 as determined by values of sUA \< 6 mg/dL at the end of Treatment Period 3 and at the end of Treatment Period 5 in eligible subjects
Outcome measures
| Measure |
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 5 Doses
SEL-212: Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses
|
SEL-037 (Pegadricase) Low Dose
n=3 Participants
Pegadricase 0.2 mg/kg IV every 28 days for up to 5 doses
|
SEL-037 (Pegadricase) High Dose
n=73 Participants
Pegadricase 0.4mg/kg IV every 28 days for up to 5 doses
|
SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
n=32 Participants
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110(0.05 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037(0.4 mg/kg) for 2 Doses
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + SEL-037 (pegadricase) 0.2 mg/kg every 28 days for 3 doses followed by SEL-037 0.2 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.125 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.125 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 5 Doses
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses
|
SEL-212: SEL-110 0.15 mg/kg + SEL-037 Low Dose x 1 Then SEL-110 0.1 mg/kg + SEL-037 Low x 4 Doses
SEL-212: Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg x 1 Then SEL-110 0.1 mg/kg + Pegadricase 0.2 mg/kg x 4 Doses
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110
Treatment Period 3
|
—
|
0 Participants
|
51 Participants
|
23 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110
Treatment Period 5
|
—
|
NA Participants
No subjects in the arm were dosed during treatment period 5
|
27 Participants
|
21 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 and 5 monthsMeasurement of the number of participants with reduced serum uric acid after multiple monthly infusions with or without SEL-110 as determined by values of sUA \< 6 mg/dL at the end of Treatment Period 3 and at the end of Treatment Period 5 in eligible subjects
Outcome measures
| Measure |
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 5 Doses
n=8 Participants
SEL-212: Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses
|
SEL-037 (Pegadricase) Low Dose
n=2 Participants
Pegadricase 0.2 mg/kg IV every 28 days for up to 5 doses
|
SEL-037 (Pegadricase) High Dose
n=1 Participants
Pegadricase 0.4mg/kg IV every 28 days for up to 5 doses
|
SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
n=6 Participants
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110(0.05 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037(0.4 mg/kg) for 2 Doses
n=5 Participants
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
n=6 Participants
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + SEL-037 (pegadricase) 0.2 mg/kg every 28 days for 3 doses followed by SEL-037 0.2 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
n=8 Participants
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
n=10 Participants
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
n=10 Participants
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.125 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
n=8 Participants
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.125 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
n=9 Participants
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
n=11 Participants
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
|
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 5 Doses
n=18 Participants
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses
|
SEL-212: SEL-110 0.15 mg/kg + SEL-037 Low Dose x 1 Then SEL-110 0.1 mg/kg + SEL-037 Low x 4 Doses
n=6 Participants
SEL-212: Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg x 1 Then SEL-110 0.1 mg/kg + Pegadricase 0.2 mg/kg x 4 Doses
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110
Treatment Period 3
|
6 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
7 Participants
|
7 Participants
|
7 Participants
|
8 Participants
|
9 Participants
|
12 Participants
|
5 Participants
|
|
Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110
Treatment Period 5
|
6 Participants
|
NA Participants
No subjects in the arm were dosed during treatment period 5
|
NA Participants
No subjects in the arm were dosed during treatment period 5
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
6 Participants
|
11 Participants
|
4 Participants
|
Adverse Events
SEL-037 (Pegadricase) Low Dose
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
SEL-037 (Pegadricase) High Dose
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
SEL-212: SEL-110 (0.125 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 5 Doses
Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths
SEL-212: SEL-110 0.15 mg/kg + SEL-037 Low x 1 Then SEL-110 0.1 mg/kg + SEL-037 Low Dose x 4 Doses
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 5 Doses
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SEL-037 (Pegadricase) Low Dose
n=3 participants at risk
Pegadricase 0.2 mg/kg IV every 28 days for up to 5 doses
|
SEL-037 (Pegadricase) High Dose
n=3 participants at risk
Pegadricase 0.4 mg/kg IV every 28 days for up to 5 doses
|
SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
n=9 participants at risk
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg IV every 28 days for 2 doses
|
SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
n=10 participants at risk
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.4 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg IV every 28 days for 2 doses
|
SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
n=6 participants at risk
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg IV every 28 days for 2 doses
|
SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
n=11 participants at risk
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.4 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg IV every 28 days for 2 doses
|
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
n=11 participants at risk
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg IV every 28 days for 2 doses
|
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
n=12 participants at risk
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.4 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg IV every 28 days for 2 doses
|
SEL-212: SEL-110 (0.125 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
n=14 participants at risk
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.125 mg/kg + Pegadricase 0.4 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg IV every 28 days for 2 doses
|
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
n=13 participants at risk
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg IV every 28 days for 2 doses
|
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
n=14 participants at risk
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.4 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg IV every 28 days for 2 doses
|
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 5 Doses
n=23 participants at risk
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 5 doses
|
SEL-212: SEL-110 0.15 mg/kg + SEL-037 Low x 1 Then SEL-110 0.1 mg/kg + SEL-037 Low Dose x 4 Doses
n=11 participants at risk
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg x 1 dose then SEL-110 0.1 mg/kg + Pegadricase 0.2 mg/kg x 4 doses IV every 28 days
|
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 5 Doses
n=12 participants at risk
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 5 doses
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Renal and urinary disorders
Micturition disorder
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
4.3%
1/23 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
4.3%
1/23 • Number of events 2 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 2 • 5 months
|
|
Gastrointestinal disorders
Acute Pancreatitis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
9.1%
1/11 • Number of events 2 • 5 months
|
0.00%
0/12 • 5 months
|
|
General disorders
Peripheral oedema
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Hepatobiliary disorders
Acute cholecystitis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Immune system disorders
Anaphylactic reaction
|
33.3%
1/3 • Number of events 1 • 5 months
|
0.00%
0/3 • 5 months
|
11.1%
1/9 • Number of events 1 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
4.3%
1/23 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/3 • 5 months
|
33.3%
1/3 • Number of events 1 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
4.3%
1/23 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
11.1%
1/9 • Number of events 1 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
9.1%
1/11 • Number of events 2 • 5 months
|
0.00%
0/12 • 5 months
|
|
Metabolism and nutrition disorders
Gout flare
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
Other adverse events
| Measure |
SEL-037 (Pegadricase) Low Dose
n=3 participants at risk
Pegadricase 0.2 mg/kg IV every 28 days for up to 5 doses
|
SEL-037 (Pegadricase) High Dose
n=3 participants at risk
Pegadricase 0.4 mg/kg IV every 28 days for up to 5 doses
|
SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
n=9 participants at risk
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg IV every 28 days for 2 doses
|
SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
n=10 participants at risk
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.4 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg IV every 28 days for 2 doses
|
SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
n=6 participants at risk
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg IV every 28 days for 2 doses
|
SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
n=11 participants at risk
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.4 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg IV every 28 days for 2 doses
|
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
n=11 participants at risk
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg IV every 28 days for 2 doses
|
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
n=12 participants at risk
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.4 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg IV every 28 days for 2 doses
|
SEL-212: SEL-110 (0.125 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
n=14 participants at risk
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.125 mg/kg + Pegadricase 0.4 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg IV every 28 days for 2 doses
|
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses
n=13 participants at risk
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg IV every 28 days for 2 doses
|
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses
n=14 participants at risk
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.4 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg IV every 28 days for 2 doses
|
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 5 Doses
n=23 participants at risk
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 5 doses
|
SEL-212: SEL-110 0.15 mg/kg + SEL-037 Low x 1 Then SEL-110 0.1 mg/kg + SEL-037 Low Dose x 4 Doses
n=11 participants at risk
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg x 1 dose then SEL-110 0.1 mg/kg + Pegadricase 0.2 mg/kg x 4 doses IV every 28 days
|
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 5 Doses
n=12 participants at risk
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 5 doses
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
4.3%
1/23 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Nervous system disorders
Formication
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
9.1%
1/11 • Number of events 6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
9.1%
1/11 • Number of events 3 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Metabolism and nutrition disorders
Gout flare
|
100.0%
3/3 • Number of events 3 • 5 months
|
0.00%
0/3 • 5 months
|
22.2%
2/9 • Number of events 2 • 5 months
|
20.0%
2/10 • Number of events 2 • 5 months
|
33.3%
2/6 • Number of events 4 • 5 months
|
18.2%
2/11 • Number of events 3 • 5 months
|
36.4%
4/11 • Number of events 8 • 5 months
|
33.3%
4/12 • Number of events 10 • 5 months
|
42.9%
6/14 • Number of events 15 • 5 months
|
30.8%
4/13 • Number of events 10 • 5 months
|
28.6%
4/14 • Number of events 10 • 5 months
|
34.8%
8/23 • Number of events 23 • 5 months
|
45.5%
5/11 • Number of events 9 • 5 months
|
41.7%
5/12 • Number of events 21 • 5 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
11.1%
1/9 • Number of events 1 • 5 months
|
0.00%
0/10 • 5 months
|
33.3%
2/6 • Number of events 2 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
7.7%
1/13 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
44.4%
4/9 • Number of events 5 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
7.7%
1/13 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
10.0%
1/10 • Number of events 1 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
14.3%
2/14 • Number of events 3 • 5 months
|
15.4%
2/13 • Number of events 2 • 5 months
|
0.00%
0/14 • 5 months
|
17.4%
4/23 • Number of events 4 • 5 months
|
27.3%
3/11 • Number of events 5 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
16.7%
1/6 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
25.0%
3/12 • Number of events 3 • 5 months
|
21.4%
3/14 • Number of events 4 • 5 months
|
7.7%
1/13 • Number of events 1 • 5 months
|
28.6%
4/14 • Number of events 5 • 5 months
|
0.00%
0/23 • 5 months
|
9.1%
1/11 • Number of events 3 • 5 months
|
0.00%
0/12 • 5 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • 5 months
|
33.3%
1/3 • Number of events 1 • 5 months
|
11.1%
1/9 • Number of events 1 • 5 months
|
10.0%
1/10 • Number of events 1 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
23.1%
3/13 • Number of events 4 • 5 months
|
0.00%
0/14 • 5 months
|
13.0%
3/23 • Number of events 3 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
40.0%
4/10 • Number of events 4 • 5 months
|
16.7%
1/6 • Number of events 1 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
27.3%
3/11 • Number of events 5 • 5 months
|
25.0%
3/12 • Number of events 6 • 5 months
|
21.4%
3/14 • Number of events 5 • 5 months
|
7.7%
1/13 • Number of events 2 • 5 months
|
21.4%
3/14 • Number of events 4 • 5 months
|
17.4%
4/23 • Number of events 8 • 5 months
|
27.3%
3/11 • Number of events 8 • 5 months
|
25.0%
3/12 • Number of events 3 • 5 months
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
33.3%
2/6 • Number of events 2 • 5 months
|
27.3%
3/11 • Number of events 4 • 5 months
|
9.1%
1/11 • Number of events 2 • 5 months
|
33.3%
4/12 • Number of events 4 • 5 months
|
21.4%
3/14 • Number of events 4 • 5 months
|
7.7%
1/13 • Number of events 2 • 5 months
|
21.4%
3/14 • Number of events 3 • 5 months
|
4.3%
1/23 • Number of events 1 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
16.7%
2/12 • Number of events 2 • 5 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
11.1%
1/9 • Number of events 1 • 5 months
|
0.00%
0/10 • 5 months
|
16.7%
1/6 • Number of events 2 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
9.1%
1/11 • Number of events 2 • 5 months
|
25.0%
3/12 • Number of events 3 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
7.7%
1/13 • Number of events 3 • 5 months
|
14.3%
2/14 • Number of events 2 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
11.1%
1/9 • Number of events 1 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
16.7%
2/12 • Number of events 2 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
8.7%
2/23 • Number of events 3 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
10.0%
1/10 • Number of events 1 • 5 months
|
16.7%
1/6 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
7.1%
1/14 • Number of events 3 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 3 • 5 months
|
8.7%
2/23 • Number of events 5 • 5 months
|
9.1%
1/11 • Number of events 2 • 5 months
|
16.7%
2/12 • Number of events 3 • 5 months
|
|
Immune system disorders
Anaphylactic reaction
|
33.3%
1/3 • Number of events 1 • 5 months
|
0.00%
0/3 • 5 months
|
11.1%
1/9 • Number of events 1 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
4.3%
1/23 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3 • 5 months
|
33.3%
1/3 • Number of events 1 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 2 • 5 months
|
7.7%
1/13 • Number of events 2 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • 5 months
|
33.3%
1/3 • Number of events 1 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
4.3%
1/23 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • 5 months
|
33.3%
1/3 • Number of events 1 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
16.7%
1/6 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
7.7%
1/13 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
8.7%
2/23 • Number of events 2 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/3 • 5 months
|
33.3%
1/3 • Number of events 1 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
11.1%
1/9 • Number of events 1 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
18.2%
2/11 • Number of events 2 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
22.2%
2/9 • Number of events 3 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 2 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 2 • 5 months
|
4.3%
1/23 • Number of events 3 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
11.1%
1/9 • Number of events 1 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
11.1%
1/9 • Number of events 1 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 3 • 5 months
|
4.3%
1/23 • Number of events 3 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
11.1%
1/9 • Number of events 1 • 5 months
|
10.0%
1/10 • Number of events 1 • 5 months
|
16.7%
1/6 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
4.3%
1/23 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
11.1%
1/9 • Number of events 1 • 5 months
|
0.00%
0/10 • 5 months
|
16.7%
1/6 • Number of events 2 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
11.1%
1/9 • Number of events 1 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
4.3%
1/23 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
11.1%
1/9 • Number of events 1 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
11.1%
1/9 • Number of events 1 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
16.7%
2/12 • Number of events 2 • 5 months
|
0.00%
0/14 • 5 months
|
7.7%
1/13 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
11.1%
1/9 • Number of events 1 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
9.1%
1/11 • Number of events 2 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
11.1%
1/9 • Number of events 1 • 5 months
|
0.00%
0/10 • 5 months
|
16.7%
1/6 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 2 • 5 months
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
11.1%
1/9 • Number of events 1 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
22.2%
2/9 • Number of events 2 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
11.1%
1/9 • Number of events 1 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
11.1%
1/9 • Number of events 1 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
4.3%
1/23 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
11.1%
1/9 • Number of events 1 • 5 months
|
0.00%
0/10 • 5 months
|
16.7%
1/6 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
11.1%
1/9 • Number of events 1 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
7.7%
1/13 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
11.1%
1/9 • Number of events 1 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Blood and lymphatic system disorders
Hyperfibrinogenaemia
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
11.1%
1/9 • Number of events 1 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
11.1%
1/9 • Number of events 1 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
11.1%
1/9 • Number of events 1 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
11.1%
1/9 • Number of events 1 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
10.0%
1/10 • Number of events 1 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
4.3%
1/23 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
10.0%
1/10 • Number of events 1 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
33.3%
2/6 • Number of events 2 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
14.3%
2/14 • Number of events 6 • 5 months
|
23.1%
3/13 • Number of events 4 • 5 months
|
7.1%
1/14 • Number of events 2 • 5 months
|
4.3%
1/23 • Number of events 1 • 5 months
|
18.2%
2/11 • Number of events 3 • 5 months
|
8.3%
1/12 • Number of events 2 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Patellofemoral pain syndrome
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
10.0%
1/10 • Number of events 1 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
10.0%
1/10 • Number of events 1 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
8.7%
2/23 • Number of events 2 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
10.0%
1/10 • Number of events 1 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
16.7%
1/6 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
16.7%
1/6 • Number of events 2 • 5 months
|
9.1%
1/11 • Number of events 4 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
33.3%
2/6 • Number of events 2 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
16.7%
1/6 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
4.3%
1/23 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
33.3%
2/6 • Number of events 3 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 2 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
16.7%
2/12 • Number of events 2 • 5 months
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
16.7%
1/6 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
16.7%
1/6 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
27.3%
3/11 • Number of events 4 • 5 months
|
16.7%
2/12 • Number of events 2 • 5 months
|
14.3%
2/14 • Number of events 2 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
8.7%
2/23 • Number of events 3 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
16.7%
1/6 • Number of events 1 • 5 months
|
18.2%
2/11 • Number of events 3 • 5 months
|
18.2%
2/11 • Number of events 2 • 5 months
|
16.7%
2/12 • Number of events 3 • 5 months
|
7.1%
1/14 • Number of events 2 • 5 months
|
0.00%
0/13 • 5 months
|
14.3%
2/14 • Number of events 2 • 5 months
|
8.7%
2/23 • Number of events 2 • 5 months
|
18.2%
2/11 • Number of events 3 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
16.7%
1/6 • Number of events 1 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
16.7%
1/6 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
7.7%
1/13 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
13.0%
3/23 • Number of events 3 • 5 months
|
9.1%
1/11 • Number of events 2 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
|
Infections and infestations
Laryngitis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
16.7%
1/6 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Gastrointestinal disorders
Bowel movement irregularity
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
16.7%
1/6 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Psychiatric disorders
Stress
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
16.7%
1/6 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
16.7%
1/6 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Investigations
Weight increased
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
16.7%
1/6 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
16.7%
1/6 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
15.4%
2/13 • Number of events 2 • 5 months
|
14.3%
2/14 • Number of events 2 • 5 months
|
13.0%
3/23 • Number of events 4 • 5 months
|
0.00%
0/11 • 5 months
|
16.7%
2/12 • Number of events 2 • 5 months
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
16.7%
1/6 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
16.7%
1/6 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
16.7%
1/6 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
16.7%
1/6 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
16.7%
1/6 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Infections and infestations
Gingivitis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
18.2%
2/11 • Number of events 2 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Nervous system disorders
Sciatica
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
9.1%
1/11 • Number of events 2 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
16.7%
2/12 • Number of events 2 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 2 • 5 months
|
4.3%
1/23 • Number of events 1 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
|
Gastrointestinal disorders
Oesophageal oedema
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
4.3%
1/23 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
9.1%
1/11 • Number of events 2 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
14.3%
2/14 • Number of events 2 • 5 months
|
8.7%
2/23 • Number of events 4 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
General disorders
Infusion site extravasation
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
General disorders
Catheter site pain
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Infections and infestations
Trichomoniasis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
4.3%
1/23 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
16.7%
2/12 • Number of events 2 • 5 months
|
0.00%
0/14 • 5 months
|
15.4%
2/13 • Number of events 3 • 5 months
|
7.1%
1/14 • Number of events 2 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
4.3%
1/23 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Vascular disorders
Vasospasm
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
9.1%
1/11 • Number of events 2 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Nervous system disorders
Migraine
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
7.7%
1/13 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
|
Skin and subcutaneous tissue disorders
alopecia
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
16.7%
2/12 • Number of events 2 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
4.3%
1/23 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
4.3%
1/23 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
16.7%
2/12 • Number of events 2 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Injury, poisoning and procedural complications
epicondylitis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 2 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
7.7%
1/13 • Number of events 1 • 5 months
|
14.3%
2/14 • Number of events 2 • 5 months
|
8.7%
2/23 • Number of events 2 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Nervous system disorders
burning sensation
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
4.3%
1/23 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Investigations
blood creatinine increased
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Cardiac disorders
atrioventricular block second degree
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Renal and urinary disorders
acute kidney injury
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Eye disorders
Swelling of eyelid
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 2 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
4.3%
1/23 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Metatarsalgia
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Gastrointestinal disorders
Oral mucosa haematoma
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 2 • 5 months
|
21.4%
3/14 • Number of events 3 • 5 months
|
7.7%
1/13 • Number of events 1 • 5 months
|
14.3%
2/14 • Number of events 4 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
4.3%
1/23 • Number of events 4 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
General disorders
Pain
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
21.4%
3/14 • Number of events 4 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
4.3%
1/23 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 5 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 3 • 5 months
|
7.7%
1/13 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
|
Investigations
aspartate aminotransferase increased
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
14.3%
2/14 • Number of events 2 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
4.3%
1/23 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Vascular disorders
Phlebitis superficial
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Vascular disorders
Varicose vein
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
4.3%
1/23 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Infections and infestations
viral upper respiratory tract infection
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
14.3%
2/14 • Number of events 2 • 5 months
|
7.7%
1/13 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
General disorders
Pyrexia
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 3 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Infections and infestations
Folliculitis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
7.7%
1/13 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
4.3%
1/23 • Number of events 2 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Infections and infestations
Prostate infection
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Cardiac disorders
Prinzmetal angina
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
4.3%
1/23 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Investigations
Heart rate increased
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
7.7%
1/13 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
4.3%
1/23 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
7.7%
1/13 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
7.7%
1/13 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
4.3%
1/23 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
7.7%
1/13 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
7.7%
1/13 • Number of events 1 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/23 • 5 months
|
18.2%
2/11 • Number of events 2 • 5 months
|
0.00%
0/12 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
7.7%
1/13 • Number of events 1 • 5 months
|
14.3%
2/14 • Number of events 2 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
General disorders
Chills
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
7.7%
1/13 • Number of events 1 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
4.3%
1/23 • Number of events 2 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
7.7%
1/13 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
|
Infections and infestations
otitis media
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
7.7%
1/13 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
7.7%
1/13 • Number of events 1 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
4.3%
1/23 • Number of events 3 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
7.7%
1/13 • Number of events 1 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Injury, poisoning and procedural complications
Ear canal abrasion
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Infections and infestations
Oral infection
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
General disorders
Fatigue
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
14.3%
2/14 • Number of events 3 • 5 months
|
0.00%
0/23 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
|
General disorders
Malaise
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Infections and infestations
Periodontitis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Infections and infestations
Body tinea
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
General disorders
Secretion discharge
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 2 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Nervous system disorders
sinus headache
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
General disorders
Chest pain
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/23 • 5 months
|
9.1%
1/11 • Number of events 2 • 5 months
|
0.00%
0/12 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Infections and infestations
Parotitis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Investigations
Blood pressure increased
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
4.3%
1/23 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Reproductive system and breast disorders
Ejaculation failure
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/23 • 5 months
|
18.2%
2/11 • Number of events 2 • 5 months
|
8.3%
1/12 • Number of events 2 • 5 months
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
14.3%
2/14 • Number of events 2 • 5 months
|
4.3%
1/23 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
4.3%
1/23 • Number of events 1 • 5 months
|
18.2%
2/11 • Number of events 3 • 5 months
|
0.00%
0/12 • 5 months
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
4.3%
1/23 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
4.3%
1/23 • Number of events 1 • 5 months
|
9.1%
1/11 • Number of events 2 • 5 months
|
0.00%
0/12 • 5 months
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
7.1%
1/14 • Number of events 1 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Infections and infestations
Rash pustular
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
4.3%
1/23 • Number of events 1 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
8.7%
2/23 • Number of events 2 • 5 months
|
27.3%
3/11 • Number of events 3 • 5 months
|
0.00%
0/12 • 5 months
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
8.7%
2/23 • Number of events 3 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
4.3%
1/23 • Number of events 1 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
9.1%
1/11 • Number of events 2 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
9.1%
1/11 • Number of events 2 • 5 months
|
0.00%
0/12 • 5 months
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
|
Investigations
Semen volume decreased
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
|
General disorders
Feeling hot
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
|
Infections and infestations
Viral infection
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
|
Nervous system disorders
Aphasia
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
9.1%
1/11 • Number of events 2 • 5 months
|
0.00%
0/12 • 5 months
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
|
Gastrointestinal disorders
Pancreatic atrophy
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
|
Vascular disorders
Hot flash
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
9.1%
1/11 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
|
Infections and infestations
Tinea manuum
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
|
Congenital, familial and genetic disorders
Buried penis syndrome
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/3 • 5 months
|
0.00%
0/3 • 5 months
|
0.00%
0/9 • 5 months
|
0.00%
0/10 • 5 months
|
0.00%
0/6 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/11 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/13 • 5 months
|
0.00%
0/14 • 5 months
|
0.00%
0/23 • 5 months
|
0.00%
0/11 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place