Trial Outcomes & Findings for Study of ARO-HBV in Normal Adult Volunteers and Patients With Hepatitis B Virus (HBV) (NCT NCT03365947)
NCT ID: NCT03365947
Last Updated: 2025-10-22
Results Overview
An adverse event (AE) is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as AEs with onset after administration of the study drug, or when a preexisting medical condition increases in severity or frequency after study drug administration. Assessment of causality utilized 3 possible categories: not related, possibly related and probably related.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
114 participants
Primary outcome timeframe
NHV participants: up to Day 29 (± 2 days); CHB participants: Day 113 (± 2 days)
Results posted on
2025-10-22
Participant Flow
Participant milestones
| Measure |
ARO-HBV 35 mg
Single dose of ARO-HBV 35 mg subcutaneous (sc) injection in normal healthy volunteers
|
ARO-HBV 100 mg
Single dose of ARO-HBV 100 mg sc injection in normal healthy volunteers
|
ARO-HBV 200 mg
Single dose of ARO-HBV 200 mg sc injection in normal healthy volunteers
|
ARO-HBV 300 mg
Single dose of ARO-HBV 300 mg sc injection in normal healthy volunteers
|
ARO-HBV 400 mg
Single dose of ARO-HBV 400 mg sc injection in normal healthy volunteers
|
Placebo
Sterile normal saline (0.9% NaCl) sc injection in normal healthy volunteers
|
ARO-HBV 25 mg, Q28D
ARO-HBV 25 mg sc injection every 28 days (Q28D) in participants with chronic hepatitis B
|
ARO-HBV 50 mg Q28D
ARO-HBV 50 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q28D
ARO-HBV 100 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 200 mg Q28D
ARO-HBV 200 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 300 mg Q28D
ARO-HBV 300 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 400 mg Q28D
ARO-HBV 400 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q14D
ARO-HBV 100 mg sc injection every 14 days (Q14D) in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q7D
ARO-HBV 100 mg sc injection every 7 days (Q7D) in participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q28D, HBeAg+/Trt Naïve
ARO-HBV 300 mg sc injection Q28D in hepatitis B e antigen positive/treatment naïve (HBeAg+/Trt Naïve) participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q28D, HBeAg+/NUC
ARO-HBV 300 mg sc injection Q28D in HBeAg+/nucleotide or nucleoside analog treated (HBeAg+/NUC) participants with chronic hepatitis B
|
ARO-HBV 200 mg, Q7D
ARO-HBV 200 mg sc injection Q7D in participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q7D
ARO-HBV 300 mg sc injection Q7D in participants with chronic hepatitis B
|
ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg
ARO-HBV 200 mg sc injection Q28D plus JNJ-56136379 250 mg in participants with chronic hepatitis B
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
4
|
4
|
10
|
8
|
8
|
8
|
8
|
8
|
8
|
4
|
4
|
4
|
4
|
4
|
4
|
12
|
|
Overall Study
COMPLETED
|
4
|
4
|
4
|
4
|
4
|
9
|
8
|
8
|
8
|
8
|
8
|
8
|
4
|
4
|
4
|
4
|
4
|
4
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
ARO-HBV 35 mg
Single dose of ARO-HBV 35 mg subcutaneous (sc) injection in normal healthy volunteers
|
ARO-HBV 100 mg
Single dose of ARO-HBV 100 mg sc injection in normal healthy volunteers
|
ARO-HBV 200 mg
Single dose of ARO-HBV 200 mg sc injection in normal healthy volunteers
|
ARO-HBV 300 mg
Single dose of ARO-HBV 300 mg sc injection in normal healthy volunteers
|
ARO-HBV 400 mg
Single dose of ARO-HBV 400 mg sc injection in normal healthy volunteers
|
Placebo
Sterile normal saline (0.9% NaCl) sc injection in normal healthy volunteers
|
ARO-HBV 25 mg, Q28D
ARO-HBV 25 mg sc injection every 28 days (Q28D) in participants with chronic hepatitis B
|
ARO-HBV 50 mg Q28D
ARO-HBV 50 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q28D
ARO-HBV 100 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 200 mg Q28D
ARO-HBV 200 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 300 mg Q28D
ARO-HBV 300 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 400 mg Q28D
ARO-HBV 400 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q14D
ARO-HBV 100 mg sc injection every 14 days (Q14D) in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q7D
ARO-HBV 100 mg sc injection every 7 days (Q7D) in participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q28D, HBeAg+/Trt Naïve
ARO-HBV 300 mg sc injection Q28D in hepatitis B e antigen positive/treatment naïve (HBeAg+/Trt Naïve) participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q28D, HBeAg+/NUC
ARO-HBV 300 mg sc injection Q28D in HBeAg+/nucleotide or nucleoside analog treated (HBeAg+/NUC) participants with chronic hepatitis B
|
ARO-HBV 200 mg, Q7D
ARO-HBV 200 mg sc injection Q7D in participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q7D
ARO-HBV 300 mg sc injection Q7D in participants with chronic hepatitis B
|
ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg
ARO-HBV 200 mg sc injection Q28D plus JNJ-56136379 250 mg in participants with chronic hepatitis B
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study of ARO-HBV in Normal Adult Volunteers and Patients With Hepatitis B Virus (HBV)
Baseline characteristics by cohort
| Measure |
ARO-HBV 35 mg
n=4 Participants
Single dose of ARO-HBV 35 mg subcutaneous (sc) injection in normal healthy volunteers
|
ARO-HBV 100 mg
n=4 Participants
Single dose of ARO-HBV 100 mg sc injection in normal healthy volunteers
|
ARO-HBV 200 mg
n=4 Participants
Single dose of ARO-HBV 200 mg sc injection in normal healthy volunteers
|
ARO-HBV 300 mg
n=4 Participants
Single dose of ARO-HBV 300 mg sc injection in normal healthy volunteers
|
ARO-HBV 400 mg
n=4 Participants
Single dose of ARO-HBV 400 mg sc injection in normal healthy volunteers
|
Placebo
n=10 Participants
Sterile normal saline (0.9% NaCl) sc injection in normal healthy volunteers
|
ARO-HBV 25 mg Q28D
n=8 Participants
ARO-HBV 25 mg sc injection every 28 days (Q28D) in participants with chronic hepatitis B
|
ARO-HBV 50 mg Q28D
n=8 Participants
ARO-HBV 50 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q28D
n=8 Participants
ARO-HBV 100 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 200 mg Q28D
n=8 Participants
ARO-HBV 200 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 300 mg Q28D
n=8 Participants
ARO-HBV 300 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 400 mg Q28D
n=8 Participants
ARO-HBV 400 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q14D
n=4 Participants
ARO-HBV 100 mg sc injection every 14 days (Q14D) in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q7D
n=4 Participants
ARO-HBV 100 mg sc injection every 7 days (Q7D) in participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q28D, HBeAg+/Trt Naïve
n=4 Participants
ARO-HBV 300 mg sc injection Q28D in HBeAg+/Treatment Naïve (HBeAg+/Trt Naïve) participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q28D, HBeAg+/NUC
n=4 Participants
ARO-HBV 300 mg sc injection Q28D in HBeAg+/nucleotide or nucleoside analog treated (HBeAg+/NUC) participants with chronic hepatitis B
|
ARO-HBV 200 mg, Q7D
n=4 Participants
ARO-HBV 200 mg sc injection Q7D in participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q7D
n=4 Participants
ARO-HBV 300 mg sc injection Q7D in participants with chronic hepatitis B
|
ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg
n=12 Participants
ARO-HBV 200 mg sc injection Q28D plus JNJ-56136379 250 mg in participants with chronic hepatitis B
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
22.0 years
STANDARD_DEVIATION 3.01 • n=5 Participants
|
23.5 years
STANDARD_DEVIATION 0.67 • n=7 Participants
|
24.8 years
STANDARD_DEVIATION 4.23 • n=5 Participants
|
28.1 years
STANDARD_DEVIATION 8.15 • n=4 Participants
|
23.6 years
STANDARD_DEVIATION 3.73 • n=21 Participants
|
27.2 years
STANDARD_DEVIATION 9.08 • n=10 Participants
|
42.8 years
STANDARD_DEVIATION 7.17 • n=115 Participants
|
47.8 years
STANDARD_DEVIATION 6.97 • n=6 Participants
|
50.8 years
STANDARD_DEVIATION 12.48 • n=6 Participants
|
47.5 years
STANDARD_DEVIATION 6.75 • n=64 Participants
|
52.1 years
STANDARD_DEVIATION 7.42 • n=17 Participants
|
41.0 years
STANDARD_DEVIATION 9.91 • n=21 Participants
|
48.9 years
STANDARD_DEVIATION 7.71 • n=22 Participants
|
40.7 years
STANDARD_DEVIATION 6.59 • n=8 Participants
|
31.8 years
STANDARD_DEVIATION 7.90 • n=16 Participants
|
36.0 years
STANDARD_DEVIATION 4.93 • n=135 Participants
|
53.2 years
STANDARD_DEVIATION 6.67 • n=136 Participants
|
50.7 years
STANDARD_DEVIATION 12.39 • n=44 Participants
|
44.9 years
STANDARD_DEVIATION 9.19 • n=667 Participants
|
40.3 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=22 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=16 Participants
|
2 Participants
n=135 Participants
|
3 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
4 Participants
n=667 Participants
|
42 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
5 Participants
n=64 Participants
|
8 Participants
n=17 Participants
|
6 Participants
n=21 Participants
|
3 Participants
n=22 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=16 Participants
|
2 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
3 Participants
n=44 Participants
|
8 Participants
n=667 Participants
|
72 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
8 Participants
n=6 Participants
|
8 Participants
n=64 Participants
|
5 Participants
n=17 Participants
|
6 Participants
n=21 Participants
|
3 Participants
n=22 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=16 Participants
|
4 Participants
n=135 Participants
|
4 Participants
n=136 Participants
|
3 Participants
n=44 Participants
|
12 Participants
n=667 Participants
|
74 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
2 Participants
n=17 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=22 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=16 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
13 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
1 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
21 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
3 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: NHV participants: up to Day 29 (± 2 days); CHB participants: Day 113 (± 2 days)Population: Safety Population: all participants who received at least 1 dose of study drug.
An adverse event (AE) is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as AEs with onset after administration of the study drug, or when a preexisting medical condition increases in severity or frequency after study drug administration. Assessment of causality utilized 3 possible categories: not related, possibly related and probably related.
Outcome measures
| Measure |
ARO-HBV 35 mg
n=4 Participants
Single dose of ARO-HBV 35 mg sc injection in normal healthy volunteers
|
ARO-HBV 100 mg
n=4 Participants
Single dose of ARO-HBV 100 mg sc injection in normal healthy volunteers
|
ARO-HBV 200 mg
n=4 Participants
Single dose of ARO-HBV 200 mg sc injection in normal healthy volunteers
|
ARO-HBV 300 mg
n=4 Participants
Single dose of ARO-HBV 300 mg sc injection in normal healthy volunteers
|
ARO-HBV 400 mg
n=4 Participants
Single dose of ARO-HBV 400 mg sc injection in normal healthy volunteers
|
Placebo
n=10 Participants
Sterile normal saline (0.9% NaCl) sc injection in normal healthy volunteers
|
ARO-HBV 25 mg Q28D
n=8 Participants
ARO-HBV 25 mg sc injection every 28 days (Q28D) in participants with chronic hepatitis B (CHB)
|
ARO-HBV 50 mg Q28D
n=8 Participants
ARO-HBV 50 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q28D
n=8 Participants
ARO-HBV 100 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 200 mg Q28D
n=8 Participants
ARO-HBV 200 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 300 mg Q28D
n=8 Participants
ARO-HBV 300 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 400 mg Q28D
n=8 Participants
ARO-HBV 400 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q14D
n=4 Participants
ARO-HBV 100 mg sc injection every 14 days (Q14D) in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q7D
n=4 Participants
ARO-HBV 100 mg sc injection every 7 days (Q7D) in participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q28D, HBeAg+/Trt Naïve
n=4 Participants
ARO-HBV 300 mg sc injection Q28D in HBeAg+/Treatment Naïve (HBeAg+/Trt Naïve) participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q28D, HBeAg+/NUC
n=4 Participants
ARO-HBV 300 mg sc injection Q28D in HBeAg+/nucleotide or nucleoside analog treated (HBeAg+/NUC) participants with chronic hepatitis B
|
ARO-HBV 200 mg, Q7D
n=4 Participants
ARO-HBV 200 mg sc injection Q7D in participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q7D
n=4 Participants
ARO-HBV 300 mg sc injection Q7D in participants with chronic hepatitis B
|
ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg
n=12 Participants
ARO-HBV 200 mg sc injection Q28D plus JNJ-56136379 250 mg in participants with chronic hepatitis B
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment
Possibly Related TEAE
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment
Probably Related TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dosePopulation: PK Population: All NHV participants receiving ARO-HBV (participants receiving placebo were excluded from the analysis per statistical analysis plan \[SAP\]). Participants with a valid assessment.
Outcome measures
| Measure |
ARO-HBV 35 mg
n=3 Participants
Single dose of ARO-HBV 35 mg sc injection in normal healthy volunteers
|
ARO-HBV 100 mg
n=4 Participants
Single dose of ARO-HBV 100 mg sc injection in normal healthy volunteers
|
ARO-HBV 200 mg
n=4 Participants
Single dose of ARO-HBV 200 mg sc injection in normal healthy volunteers
|
ARO-HBV 300 mg
n=4 Participants
Single dose of ARO-HBV 300 mg sc injection in normal healthy volunteers
|
ARO-HBV 400 mg
n=4 Participants
Single dose of ARO-HBV 400 mg sc injection in normal healthy volunteers
|
Placebo
Sterile normal saline (0.9% NaCl) sc injection in normal healthy volunteers
|
ARO-HBV 25 mg Q28D
ARO-HBV 25 mg sc injection every 28 days (Q28D) in participants with chronic hepatitis B (CHB)
|
ARO-HBV 50 mg Q28D
ARO-HBV 50 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q28D
ARO-HBV 100 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 200 mg Q28D
ARO-HBV 200 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 300 mg Q28D
ARO-HBV 300 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 400 mg Q28D
ARO-HBV 400 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q14D
ARO-HBV 100 mg sc injection every 14 days (Q14D) in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q7D
ARO-HBV 100 mg sc injection every 7 days (Q7D) in participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q28D, HBeAg+/Trt Naïve
ARO-HBV 300 mg sc injection Q28D in HBeAg+/Treatment Naïve (HBeAg+/Trt Naïve) participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q28D, HBeAg+/NUC
ARO-HBV 300 mg sc injection Q28D in HBeAg+/nucleotide or nucleoside analog treated (HBeAg+/NUC) participants with chronic hepatitis B
|
ARO-HBV 200 mg, Q7D
ARO-HBV 200 mg sc injection Q7D in participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q7D
ARO-HBV 300 mg sc injection Q7D in participants with chronic hepatitis B
|
ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg
ARO-HBV 200 mg sc injection Q28D plus JNJ-56136379 250 mg in participants with chronic hepatitis B
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A, Pharmacokinetics (PK) of ARO-HBV Analytes: Maximum Observed Plasma Concentration (Cmax)
Analyte: JNJ-73763976
|
160 ng/mL
Standard Deviation 106
|
536 ng/mL
Standard Deviation 390
|
1320 ng/mL
Standard Deviation 331
|
2920 ng/mL
Standard Deviation 1670
|
4280 ng/mL
Standard Deviation 1340
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A, Pharmacokinetics (PK) of ARO-HBV Analytes: Maximum Observed Plasma Concentration (Cmax)
Analyte: JNJ-73763924
|
43.0 ng/mL
Standard Deviation 25.8
|
117 ng/mL
Standard Deviation 45.2
|
363 ng/mL
Standard Deviation 89.5
|
827 ng/mL
Standard Deviation 447
|
1010 ng/mL
Standard Deviation 398
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dosePopulation: PK Population: All NHV participants receiving ARO-HBV (participants receiving placebo were excluded from the analysis per SAP). Participants with a valid assessment.
Outcome measures
| Measure |
ARO-HBV 35 mg
n=3 Participants
Single dose of ARO-HBV 35 mg sc injection in normal healthy volunteers
|
ARO-HBV 100 mg
n=4 Participants
Single dose of ARO-HBV 100 mg sc injection in normal healthy volunteers
|
ARO-HBV 200 mg
n=4 Participants
Single dose of ARO-HBV 200 mg sc injection in normal healthy volunteers
|
ARO-HBV 300 mg
n=4 Participants
Single dose of ARO-HBV 300 mg sc injection in normal healthy volunteers
|
ARO-HBV 400 mg
n=4 Participants
Single dose of ARO-HBV 400 mg sc injection in normal healthy volunteers
|
Placebo
Sterile normal saline (0.9% NaCl) sc injection in normal healthy volunteers
|
ARO-HBV 25 mg Q28D
ARO-HBV 25 mg sc injection every 28 days (Q28D) in participants with chronic hepatitis B (CHB)
|
ARO-HBV 50 mg Q28D
ARO-HBV 50 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q28D
ARO-HBV 100 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 200 mg Q28D
ARO-HBV 200 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 300 mg Q28D
ARO-HBV 300 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 400 mg Q28D
ARO-HBV 400 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q14D
ARO-HBV 100 mg sc injection every 14 days (Q14D) in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q7D
ARO-HBV 100 mg sc injection every 7 days (Q7D) in participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q28D, HBeAg+/Trt Naïve
ARO-HBV 300 mg sc injection Q28D in HBeAg+/Treatment Naïve (HBeAg+/Trt Naïve) participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q28D, HBeAg+/NUC
ARO-HBV 300 mg sc injection Q28D in HBeAg+/nucleotide or nucleoside analog treated (HBeAg+/NUC) participants with chronic hepatitis B
|
ARO-HBV 200 mg, Q7D
ARO-HBV 200 mg sc injection Q7D in participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q7D
ARO-HBV 300 mg sc injection Q7D in participants with chronic hepatitis B
|
ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg
ARO-HBV 200 mg sc injection Q28D plus JNJ-56136379 250 mg in participants with chronic hepatitis B
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A, PK of ARO-HBV Analytes : Time to Maximum Plasma Concentration (Tmax)
Analyte: JNJ-73763976
|
6.00 hours
Interval 6.0 to 6.03
|
6.00 hours
Interval 3.0 to 6.0
|
6.00 hours
Interval 2.0 to 6.0
|
6.03 hours
Interval 2.0 to 6.05
|
6.00 hours
Interval 6.0 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A, PK of ARO-HBV Analytes : Time to Maximum Plasma Concentration (Tmax)
Analyte: JNJ-73763924
|
6.00 hours
Interval 2.0 to 6.0
|
6.00 hours
Interval 2.0 to 6.0
|
1.50 hours
Interval 0.5 to 6.0
|
2.02 hours
Interval 1.0 to 3.0
|
6.00 hours
Interval 6.0 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 hours post-dosePopulation: PK Population: All NHV participants receiving ARO-HBV (participants receiving placebo were excluded from the analysis per SAP). Participants with a valid assessment.
Outcome measures
| Measure |
ARO-HBV 35 mg
n=3 Participants
Single dose of ARO-HBV 35 mg sc injection in normal healthy volunteers
|
ARO-HBV 100 mg
n=4 Participants
Single dose of ARO-HBV 100 mg sc injection in normal healthy volunteers
|
ARO-HBV 200 mg
n=4 Participants
Single dose of ARO-HBV 200 mg sc injection in normal healthy volunteers
|
ARO-HBV 300 mg
n=4 Participants
Single dose of ARO-HBV 300 mg sc injection in normal healthy volunteers
|
ARO-HBV 400 mg
n=4 Participants
Single dose of ARO-HBV 400 mg sc injection in normal healthy volunteers
|
Placebo
Sterile normal saline (0.9% NaCl) sc injection in normal healthy volunteers
|
ARO-HBV 25 mg Q28D
ARO-HBV 25 mg sc injection every 28 days (Q28D) in participants with chronic hepatitis B (CHB)
|
ARO-HBV 50 mg Q28D
ARO-HBV 50 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q28D
ARO-HBV 100 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 200 mg Q28D
ARO-HBV 200 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 300 mg Q28D
ARO-HBV 300 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 400 mg Q28D
ARO-HBV 400 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q14D
ARO-HBV 100 mg sc injection every 14 days (Q14D) in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q7D
ARO-HBV 100 mg sc injection every 7 days (Q7D) in participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q28D, HBeAg+/Trt Naïve
ARO-HBV 300 mg sc injection Q28D in HBeAg+/Treatment Naïve (HBeAg+/Trt Naïve) participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q28D, HBeAg+/NUC
ARO-HBV 300 mg sc injection Q28D in HBeAg+/nucleotide or nucleoside analog treated (HBeAg+/NUC) participants with chronic hepatitis B
|
ARO-HBV 200 mg, Q7D
ARO-HBV 200 mg sc injection Q7D in participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q7D
ARO-HBV 300 mg sc injection Q7D in participants with chronic hepatitis B
|
ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg
ARO-HBV 200 mg sc injection Q28D plus JNJ-56136379 250 mg in participants with chronic hepatitis B
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24)
Analyte: JNJ-76763976
|
1830 h*ng/mL
Standard Deviation 1190
|
5480 h*ng/mL
Standard Deviation 2540
|
17800 h*ng/mL
Standard Deviation 4180
|
35500 h*ng/mL
Standard Deviation 17200
|
44600 h*ng/mL
Standard Deviation 15100
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24)
Analyte: JNJ-76763924
|
327 h*ng/mL
Standard Deviation NA
1 participant analyzed
|
1250 h*ng/mL
Standard Deviation 330
|
4320 h*ng/mL
Standard Deviation 965
|
8140 h*ng/mL
Standard Deviation 3160
|
9720 h*ng/mL
Standard Deviation 3680
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dosePopulation: PK Population: All NHV participants receiving ARO-HBV (participants receiving placebo were excluded from the analysis per SAP). Participants with a valid assessment.
Outcome measures
| Measure |
ARO-HBV 35 mg
n=1 Participants
Single dose of ARO-HBV 35 mg sc injection in normal healthy volunteers
|
ARO-HBV 100 mg
n=1 Participants
Single dose of ARO-HBV 100 mg sc injection in normal healthy volunteers
|
ARO-HBV 200 mg
n=3 Participants
Single dose of ARO-HBV 200 mg sc injection in normal healthy volunteers
|
ARO-HBV 300 mg
n=3 Participants
Single dose of ARO-HBV 300 mg sc injection in normal healthy volunteers
|
ARO-HBV 400 mg
Single dose of ARO-HBV 400 mg sc injection in normal healthy volunteers
|
Placebo
Sterile normal saline (0.9% NaCl) sc injection in normal healthy volunteers
|
ARO-HBV 25 mg Q28D
ARO-HBV 25 mg sc injection every 28 days (Q28D) in participants with chronic hepatitis B (CHB)
|
ARO-HBV 50 mg Q28D
ARO-HBV 50 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q28D
ARO-HBV 100 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 200 mg Q28D
ARO-HBV 200 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 300 mg Q28D
ARO-HBV 300 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 400 mg Q28D
ARO-HBV 400 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q14D
ARO-HBV 100 mg sc injection every 14 days (Q14D) in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q7D
ARO-HBV 100 mg sc injection every 7 days (Q7D) in participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q28D, HBeAg+/Trt Naïve
ARO-HBV 300 mg sc injection Q28D in HBeAg+/Treatment Naïve (HBeAg+/Trt Naïve) participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q28D, HBeAg+/NUC
ARO-HBV 300 mg sc injection Q28D in HBeAg+/nucleotide or nucleoside analog treated (HBeAg+/NUC) participants with chronic hepatitis B
|
ARO-HBV 200 mg, Q7D
ARO-HBV 200 mg sc injection Q7D in participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q7D
ARO-HBV 300 mg sc injection Q7D in participants with chronic hepatitis B
|
ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg
ARO-HBV 200 mg sc injection Q28D plus JNJ-56136379 250 mg in participants with chronic hepatitis B
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUCinf)
Analyte: JNJ-6763976
|
—
|
5820 h*ng/mL
Standard Deviation NA
1 participant analyzed
|
12600 h*ng/mL
Standard Deviation NA
1 participant analyzed
|
14800 h*ng/mL
Standard Deviation NA
1 participant analyzed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUCinf)
Analyte: JNJ-76763924
|
365 h*ng/mL
Standard Deviation NA
1 participant analyzed
|
1530 h*ng/mL
Standard Deviation NA
1 participant analyzed
|
4610 h*ng/mL
Standard Deviation 1190
|
8170 h*ng/mL
Standard Deviation 3420
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dosePopulation: PK Population: All NHV participants receiving ARO-HBV (participants receiving placebo were excluded from the analysis per SAP). Participants with a valid assessment.
Outcome measures
| Measure |
ARO-HBV 35 mg
n=3 Participants
Single dose of ARO-HBV 35 mg sc injection in normal healthy volunteers
|
ARO-HBV 100 mg
n=4 Participants
Single dose of ARO-HBV 100 mg sc injection in normal healthy volunteers
|
ARO-HBV 200 mg
n=4 Participants
Single dose of ARO-HBV 200 mg sc injection in normal healthy volunteers
|
ARO-HBV 300 mg
n=4 Participants
Single dose of ARO-HBV 300 mg sc injection in normal healthy volunteers
|
ARO-HBV 400 mg
n=4 Participants
Single dose of ARO-HBV 400 mg sc injection in normal healthy volunteers
|
Placebo
Sterile normal saline (0.9% NaCl) sc injection in normal healthy volunteers
|
ARO-HBV 25 mg Q28D
ARO-HBV 25 mg sc injection every 28 days (Q28D) in participants with chronic hepatitis B (CHB)
|
ARO-HBV 50 mg Q28D
ARO-HBV 50 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q28D
ARO-HBV 100 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 200 mg Q28D
ARO-HBV 200 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 300 mg Q28D
ARO-HBV 300 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 400 mg Q28D
ARO-HBV 400 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q14D
ARO-HBV 100 mg sc injection every 14 days (Q14D) in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q7D
ARO-HBV 100 mg sc injection every 7 days (Q7D) in participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q28D, HBeAg+/Trt Naïve
ARO-HBV 300 mg sc injection Q28D in HBeAg+/Treatment Naïve (HBeAg+/Trt Naïve) participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q28D, HBeAg+/NUC
ARO-HBV 300 mg sc injection Q28D in HBeAg+/nucleotide or nucleoside analog treated (HBeAg+/NUC) participants with chronic hepatitis B
|
ARO-HBV 200 mg, Q7D
ARO-HBV 200 mg sc injection Q7D in participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q7D
ARO-HBV 300 mg sc injection Q7D in participants with chronic hepatitis B
|
ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg
ARO-HBV 200 mg sc injection Q28D plus JNJ-56136379 250 mg in participants with chronic hepatitis B
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to the Time of the Last Quantifiable Concentration (AUC0-t)
Analyte: JNJ-76763976
|
1830 h*ng/mL
Standard Deviation 1190
|
5740 h*ng/mL
Standard Deviation 2480
|
20100 h*ng/mL
Standard Deviation 5250
|
37900 h*ng/mL
Standard Deviation 16900
|
46900 h*ng/mL
Standard Deviation 17400
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to the Time of the Last Quantifiable Concentration (AUC0-t)
Analyte: JNJ-76763924
|
254 h*ng/mL
Standard Deviation 127
|
1250 h*ng/mL
Standard Deviation 330
|
4600 h*ng/mL
Standard Deviation 1130
|
8330 h*ng/mL
Standard Deviation 2820
|
9940 h*ng/mL
Standard Deviation 3990
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dosePopulation: PK Population: All NHV participants receiving ARO-HBV (participants receiving placebo were excluded from the analysis per SAP). Participants with a valid assessment.
Outcome measures
| Measure |
ARO-HBV 35 mg
n=1 Participants
Single dose of ARO-HBV 35 mg sc injection in normal healthy volunteers
|
ARO-HBV 100 mg
n=1 Participants
Single dose of ARO-HBV 100 mg sc injection in normal healthy volunteers
|
ARO-HBV 200 mg
n=3 Participants
Single dose of ARO-HBV 200 mg sc injection in normal healthy volunteers
|
ARO-HBV 300 mg
n=3 Participants
Single dose of ARO-HBV 300 mg sc injection in normal healthy volunteers
|
ARO-HBV 400 mg
Single dose of ARO-HBV 400 mg sc injection in normal healthy volunteers
|
Placebo
Sterile normal saline (0.9% NaCl) sc injection in normal healthy volunteers
|
ARO-HBV 25 mg Q28D
ARO-HBV 25 mg sc injection every 28 days (Q28D) in participants with chronic hepatitis B (CHB)
|
ARO-HBV 50 mg Q28D
ARO-HBV 50 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q28D
ARO-HBV 100 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 200 mg Q28D
ARO-HBV 200 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 300 mg Q28D
ARO-HBV 300 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 400 mg Q28D
ARO-HBV 400 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q14D
ARO-HBV 100 mg sc injection every 14 days (Q14D) in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q7D
ARO-HBV 100 mg sc injection every 7 days (Q7D) in participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q28D, HBeAg+/Trt Naïve
ARO-HBV 300 mg sc injection Q28D in HBeAg+/Treatment Naïve (HBeAg+/Trt Naïve) participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q28D, HBeAg+/NUC
ARO-HBV 300 mg sc injection Q28D in HBeAg+/nucleotide or nucleoside analog treated (HBeAg+/NUC) participants with chronic hepatitis B
|
ARO-HBV 200 mg, Q7D
ARO-HBV 200 mg sc injection Q7D in participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q7D
ARO-HBV 300 mg sc injection Q7D in participants with chronic hepatitis B
|
ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg
ARO-HBV 200 mg sc injection Q28D plus JNJ-56136379 250 mg in participants with chronic hepatitis B
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A, PK of ARO-HBV Analytes: Terminal Elimination Half-Life (t½)
Analyte: JNJ-6763976
|
—
|
6.45 hours
Standard Deviation NA
1 participant analyzed
|
5.83 hours
Standard Deviation NA
1 participant analyzed
|
9.16 hours
Standard Deviation NA
1 participant analyzed
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A, PK of ARO-HBV Analytes: Terminal Elimination Half-Life (t½)
Analyte: JNJ-76763924
|
7.52 hours
Standard Deviation NA
1 participant analyzed
|
5.97 hours
Standard Deviation NA
1 participant analyzed
|
6.48 hours
Standard Deviation 1.23
|
6.02 hours
Standard Deviation 2.34
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 hours post-dosePopulation: PK Population: All NHV participants receiving ARO-HBV (participants receiving placebo were excluded from the analysis per SAP). Participants with a valid assessment.
Outcome measures
| Measure |
ARO-HBV 35 mg
n=3 Participants
Single dose of ARO-HBV 35 mg sc injection in normal healthy volunteers
|
ARO-HBV 100 mg
n=4 Participants
Single dose of ARO-HBV 100 mg sc injection in normal healthy volunteers
|
ARO-HBV 200 mg
n=4 Participants
Single dose of ARO-HBV 200 mg sc injection in normal healthy volunteers
|
ARO-HBV 300 mg
n=4 Participants
Single dose of ARO-HBV 300 mg sc injection in normal healthy volunteers
|
ARO-HBV 400 mg
n=4 Participants
Single dose of ARO-HBV 400 mg sc injection in normal healthy volunteers
|
Placebo
Sterile normal saline (0.9% NaCl) sc injection in normal healthy volunteers
|
ARO-HBV 25 mg Q28D
ARO-HBV 25 mg sc injection every 28 days (Q28D) in participants with chronic hepatitis B (CHB)
|
ARO-HBV 50 mg Q28D
ARO-HBV 50 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q28D
ARO-HBV 100 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 200 mg Q28D
ARO-HBV 200 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 300 mg Q28D
ARO-HBV 300 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 400 mg Q28D
ARO-HBV 400 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q14D
ARO-HBV 100 mg sc injection every 14 days (Q14D) in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q7D
ARO-HBV 100 mg sc injection every 7 days (Q7D) in participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q28D, HBeAg+/Trt Naïve
ARO-HBV 300 mg sc injection Q28D in HBeAg+/Treatment Naïve (HBeAg+/Trt Naïve) participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q28D, HBeAg+/NUC
ARO-HBV 300 mg sc injection Q28D in HBeAg+/nucleotide or nucleoside analog treated (HBeAg+/NUC) participants with chronic hepatitis B
|
ARO-HBV 200 mg, Q7D
ARO-HBV 200 mg sc injection Q7D in participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q7D
ARO-HBV 300 mg sc injection Q7D in participants with chronic hepatitis B
|
ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg
ARO-HBV 200 mg sc injection Q28D plus JNJ-56136379 250 mg in participants with chronic hepatitis B
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-24
Analyte: NJ-76763976
|
52.1 h*ng/mL/mg
Standard Deviation 34.1
|
54.8 h*ng/mL/mg
Standard Deviation 25.4
|
88.9 h*ng/mL/mg
Standard Deviation 20.9
|
118 h*ng/mL/mg
Standard Deviation 57.3
|
111 h*ng/mL/mg
Standard Deviation 37.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-24
Analyte: JNJ-6763924
|
9.34 h*ng/mL/mg
Standard Deviation NA
1 participant analyzed
|
12.5 h*ng/mL/mg
Standard Deviation 3.30
|
21.6 h*ng/mL/mg
Standard Deviation 4.83
|
27.1 h*ng/mL/mg
Standard Deviation 10.5
|
24.3 h*ng/mL/mg
Standard Deviation 9.20
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dosePopulation: PK Population: All NHV participants receiving ARO-HBV (participants receiving placebo were excluded from the analysis per SAP). Participants with a valid assessment.
Outcome measures
| Measure |
ARO-HBV 35 mg
n=3 Participants
Single dose of ARO-HBV 35 mg sc injection in normal healthy volunteers
|
ARO-HBV 100 mg
n=4 Participants
Single dose of ARO-HBV 100 mg sc injection in normal healthy volunteers
|
ARO-HBV 200 mg
n=4 Participants
Single dose of ARO-HBV 200 mg sc injection in normal healthy volunteers
|
ARO-HBV 300 mg
n=4 Participants
Single dose of ARO-HBV 300 mg sc injection in normal healthy volunteers
|
ARO-HBV 400 mg
n=4 Participants
Single dose of ARO-HBV 400 mg sc injection in normal healthy volunteers
|
Placebo
Sterile normal saline (0.9% NaCl) sc injection in normal healthy volunteers
|
ARO-HBV 25 mg Q28D
ARO-HBV 25 mg sc injection every 28 days (Q28D) in participants with chronic hepatitis B (CHB)
|
ARO-HBV 50 mg Q28D
ARO-HBV 50 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q28D
ARO-HBV 100 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 200 mg Q28D
ARO-HBV 200 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 300 mg Q28D
ARO-HBV 300 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 400 mg Q28D
ARO-HBV 400 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q14D
ARO-HBV 100 mg sc injection every 14 days (Q14D) in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q7D
ARO-HBV 100 mg sc injection every 7 days (Q7D) in participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q28D, HBeAg+/Trt Naïve
ARO-HBV 300 mg sc injection Q28D in HBeAg+/Treatment Naïve (HBeAg+/Trt Naïve) participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q28D, HBeAg+/NUC
ARO-HBV 300 mg sc injection Q28D in HBeAg+/nucleotide or nucleoside analog treated (HBeAg+/NUC) participants with chronic hepatitis B
|
ARO-HBV 200 mg, Q7D
ARO-HBV 200 mg sc injection Q7D in participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q7D
ARO-HBV 300 mg sc injection Q7D in participants with chronic hepatitis B
|
ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg
ARO-HBV 200 mg sc injection Q28D plus JNJ-56136379 250 mg in participants with chronic hepatitis B
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-t
Analyte: JNJ-6763976
|
52.1 h*ng/mL/mg
Standard Deviation 34.1
|
57.4 h*ng/mL/mg
Standard Deviation 24.8
|
101 h*ng/mL/mg
Standard Deviation 26.3
|
126 h*ng/mL/mg
Standard Deviation 56.5
|
117 h*ng/mL/mg
Standard Deviation 43.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-t
Analyte:JNJ-76763924
|
7.25 h*ng/mL/mg
Standard Deviation 3.63
|
12.5 h*ng/mL/mg
Standard Deviation 3.30
|
23.0 h*ng/mL/mg
Standard Deviation 5.65
|
27.8 h*ng/mL/mg
Standard Deviation 9.39
|
24.8 h*ng/mL/mg
Standard Deviation 9.98
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dosePopulation: PK Population: All NHV participants receiving ARO-HBV (participants receiving placebo were excluded from the analysis per SAP). Participants with a valid assessment.
Outcome measures
| Measure |
ARO-HBV 35 mg
n=3 Participants
Single dose of ARO-HBV 35 mg sc injection in normal healthy volunteers
|
ARO-HBV 100 mg
n=4 Participants
Single dose of ARO-HBV 100 mg sc injection in normal healthy volunteers
|
ARO-HBV 200 mg
n=4 Participants
Single dose of ARO-HBV 200 mg sc injection in normal healthy volunteers
|
ARO-HBV 300 mg
n=4 Participants
Single dose of ARO-HBV 300 mg sc injection in normal healthy volunteers
|
ARO-HBV 400 mg
n=4 Participants
Single dose of ARO-HBV 400 mg sc injection in normal healthy volunteers
|
Placebo
Sterile normal saline (0.9% NaCl) sc injection in normal healthy volunteers
|
ARO-HBV 25 mg Q28D
ARO-HBV 25 mg sc injection every 28 days (Q28D) in participants with chronic hepatitis B (CHB)
|
ARO-HBV 50 mg Q28D
ARO-HBV 50 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q28D
ARO-HBV 100 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 200 mg Q28D
ARO-HBV 200 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 300 mg Q28D
ARO-HBV 300 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 400 mg Q28D
ARO-HBV 400 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q14D
ARO-HBV 100 mg sc injection every 14 days (Q14D) in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q7D
ARO-HBV 100 mg sc injection every 7 days (Q7D) in participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q28D, HBeAg+/Trt Naïve
ARO-HBV 300 mg sc injection Q28D in HBeAg+/Treatment Naïve (HBeAg+/Trt Naïve) participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q28D, HBeAg+/NUC
ARO-HBV 300 mg sc injection Q28D in HBeAg+/nucleotide or nucleoside analog treated (HBeAg+/NUC) participants with chronic hepatitis B
|
ARO-HBV 200 mg, Q7D
ARO-HBV 200 mg sc injection Q7D in participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q7D
ARO-HBV 300 mg sc injection Q7D in participants with chronic hepatitis B
|
ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg
ARO-HBV 200 mg sc injection Q28D plus JNJ-56136379 250 mg in participants with chronic hepatitis B
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A, PK of ARO-HBV Analytes: Dose-Normalized Cmax
Analyte: JNJ-76763924
|
1.23 ng/mL/mg
Standard Deviation 0.737
|
1.17 ng/mL/mg
Standard Deviation 0.452
|
1.81 ng/mL/mg
Standard Deviation 0.448
|
2.76 ng/mL/mg
Standard Deviation 1.49
|
2.53 ng/mL/mg
Standard Deviation 0.994
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A, PK of ARO-HBV Analytes: Dose-Normalized Cmax
Analyte: JNJ-76763976
|
4.56 ng/mL/mg
Standard Deviation 3.03
|
5.36 ng/mL/mg
Standard Deviation 3.90
|
6.58 ng/mL/mg
Standard Deviation 1.65
|
9.72 ng/mL/mg
Standard Deviation 5.58
|
10.7 ng/mL/mg
Standard Deviation 3.34
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part B (multiple-ascending dose [MAD] phase) only: up to 113 daysPopulation: Pharmacodynamic (PD) Population: participants who received at least one dose of study treatment and had PD assessment from baseline and assessment from post-baseline.
Outcome measures
| Measure |
ARO-HBV 35 mg
n=8 Participants
Single dose of ARO-HBV 35 mg sc injection in normal healthy volunteers
|
ARO-HBV 100 mg
n=8 Participants
Single dose of ARO-HBV 100 mg sc injection in normal healthy volunteers
|
ARO-HBV 200 mg
n=8 Participants
Single dose of ARO-HBV 200 mg sc injection in normal healthy volunteers
|
ARO-HBV 300 mg
n=8 Participants
Single dose of ARO-HBV 300 mg sc injection in normal healthy volunteers
|
ARO-HBV 400 mg
n=8 Participants
Single dose of ARO-HBV 400 mg sc injection in normal healthy volunteers
|
Placebo
n=8 Participants
Sterile normal saline (0.9% NaCl) sc injection in normal healthy volunteers
|
ARO-HBV 25 mg Q28D
n=4 Participants
ARO-HBV 25 mg sc injection every 28 days (Q28D) in participants with chronic hepatitis B (CHB)
|
ARO-HBV 50 mg Q28D
n=4 Participants
ARO-HBV 50 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q28D
n=4 Participants
ARO-HBV 100 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 200 mg Q28D
n=4 Participants
ARO-HBV 200 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 300 mg Q28D
n=4 Participants
ARO-HBV 300 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 400 mg Q28D
n=4 Participants
ARO-HBV 400 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q14D
n=12 Participants
ARO-HBV 100 mg sc injection every 14 days (Q14D) in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q7D
ARO-HBV 100 mg sc injection every 7 days (Q7D) in participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q28D, HBeAg+/Trt Naïve
ARO-HBV 300 mg sc injection Q28D in HBeAg+/Treatment Naïve (HBeAg+/Trt Naïve) participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q28D, HBeAg+/NUC
ARO-HBV 300 mg sc injection Q28D in HBeAg+/nucleotide or nucleoside analog treated (HBeAg+/NUC) participants with chronic hepatitis B
|
ARO-HBV 200 mg, Q7D
ARO-HBV 200 mg sc injection Q7D in participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q7D
ARO-HBV 300 mg sc injection Q7D in participants with chronic hepatitis B
|
ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg
ARO-HBV 200 mg sc injection Q28D plus JNJ-56136379 250 mg in participants with chronic hepatitis B
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in HBV Surface Antigen (HBsAg) From Day 1 Pre-Dose Baseline to Post-Dose Nadir in Participants Chronically Infected With HBV
|
-1.083 IU/mL
Standard Deviation 0.5320
|
-1.199 IU/mL
Standard Deviation 0.2525
|
-1.695 IU/mL
Standard Deviation 0.4921
|
-1.769 IU/mL
Standard Deviation 0.4018
|
-1.534 IU/mL
Standard Deviation 0.3080
|
-1.889 IU/mL
Standard Deviation 0.6948
|
-1.549 IU/mL
Standard Deviation 0.2956
|
-1.412 IU/mL
Standard Deviation 0.4153
|
-2.252 IU/mL
Standard Deviation 1.0177
|
-2.492 IU/mL
Standard Deviation 0.6493
|
-2.316 IU/mL
Standard Deviation 0.6979
|
-1.879 IU/mL
Standard Deviation 0.2676
|
-1.687 IU/mL
Standard Deviation 0.3887
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
ARO-HBV 35 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
ARO-HBV 100 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
ARO-HBV 200 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
ARO-HBV 300 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
ARO-HBV 400 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
ARO-HBV 25 mg Q28D
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
ARO-HBV 50 mg Q28D
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
ARO-HBV 100 mg Q28D
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
ARO-HBV 200 mg Q28D
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
ARO-HBV 300 mg Q28D
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
ARO-HBV 400 mg Q28D
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
ARO-HBV 100 mg Q14D
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
ARO-HBV 100 mg Q7D
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
ARO-HBV 300 mg, Q28D, HBeAg+/Trt Naïve
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
ARO-HBV 300 mg, Q28D, HBeAg+/NUC
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
ARO-HBV 200 mg, Q7D
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
ARO-HBV 300 mg, Q7D
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ARO-HBV 35 mg
n=4 participants at risk
Single dose of ARO-HBV 35 mg sc injection in normal healthy volunteers
|
ARO-HBV 100 mg
n=4 participants at risk
Single dose of ARO-HBV 100 mg sc injection in normal healthy volunteers
|
ARO-HBV 200 mg
n=4 participants at risk
Single dose of ARO-HBV 200 mg sc injection in normal healthy volunteers
|
ARO-HBV 300 mg
n=4 participants at risk
Single dose of ARO-HBV 300 mg sc injection in normal healthy volunteers
|
ARO-HBV 400 mg
n=4 participants at risk
Single dose of ARO-HBV 400 mg sc injection in normal healthy volunteers
|
Placebo
n=10 participants at risk
Sterile normal saline (0.9% NaCl) sc injection in normal healthy volunteers
|
ARO-HBV 25 mg Q28D
n=8 participants at risk
ARO-HBV 25 mg sc injection every 28 days (Q28D) in participants with chronic hepatitis B (CHB)
|
ARO-HBV 50 mg Q28D
n=8 participants at risk
ARO-HBV 50 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q28D
n=8 participants at risk
ARO-HBV 100 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 200 mg Q28D
n=8 participants at risk
ARO-HBV 200 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 300 mg Q28D
n=8 participants at risk
ARO-HBV 300 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 400 mg Q28D
n=8 participants at risk
ARO-HBV 400 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q14D
n=4 participants at risk
ARO-HBV 100 mg sc injection every 14 days (Q14D) in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q7D
n=4 participants at risk
ARO-HBV 100 mg sc injection every 7 days (Q7D) in participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q28D, HBeAg+/Trt Naïve
n=4 participants at risk
ARO-HBV 300 mg sc injection Q28D in HBeAg+/Treatment Naïve (HBeAg+/Trt Naïve) participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q28D, HBeAg+/NUC
n=4 participants at risk
ARO-HBV 300 mg sc injection Q28D in HBeAg+/nucleotide or nucleoside analog treated (HBeAg+/NUC) participants with chronic hepatitis B
|
ARO-HBV 200 mg, Q7D
n=4 participants at risk
ARO-HBV 200 mg sc injection Q7D in participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q7D
n=4 participants at risk
ARO-HBV 300 mg sc injection Q7D in participants with chronic hepatitis B
|
ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg
n=12 participants at risk
ARO-HBV 200 mg sc injection Q28D plus JNJ-56136379 250 mg in participants with chronic hepatitis B
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Gastrointestinal disorders
Retroperitoneal mass
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
8.3%
1/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
Other adverse events
| Measure |
ARO-HBV 35 mg
n=4 participants at risk
Single dose of ARO-HBV 35 mg sc injection in normal healthy volunteers
|
ARO-HBV 100 mg
n=4 participants at risk
Single dose of ARO-HBV 100 mg sc injection in normal healthy volunteers
|
ARO-HBV 200 mg
n=4 participants at risk
Single dose of ARO-HBV 200 mg sc injection in normal healthy volunteers
|
ARO-HBV 300 mg
n=4 participants at risk
Single dose of ARO-HBV 300 mg sc injection in normal healthy volunteers
|
ARO-HBV 400 mg
n=4 participants at risk
Single dose of ARO-HBV 400 mg sc injection in normal healthy volunteers
|
Placebo
n=10 participants at risk
Sterile normal saline (0.9% NaCl) sc injection in normal healthy volunteers
|
ARO-HBV 25 mg Q28D
n=8 participants at risk
ARO-HBV 25 mg sc injection every 28 days (Q28D) in participants with chronic hepatitis B (CHB)
|
ARO-HBV 50 mg Q28D
n=8 participants at risk
ARO-HBV 50 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q28D
n=8 participants at risk
ARO-HBV 100 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 200 mg Q28D
n=8 participants at risk
ARO-HBV 200 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 300 mg Q28D
n=8 participants at risk
ARO-HBV 300 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 400 mg Q28D
n=8 participants at risk
ARO-HBV 400 mg sc injection Q28D in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q14D
n=4 participants at risk
ARO-HBV 100 mg sc injection every 14 days (Q14D) in participants with chronic hepatitis B
|
ARO-HBV 100 mg Q7D
n=4 participants at risk
ARO-HBV 100 mg sc injection every 7 days (Q7D) in participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q28D, HBeAg+/Trt Naïve
n=4 participants at risk
ARO-HBV 300 mg sc injection Q28D in HBeAg+/Treatment Naïve (HBeAg+/Trt Naïve) participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q28D, HBeAg+/NUC
n=4 participants at risk
ARO-HBV 300 mg sc injection Q28D in HBeAg+/nucleotide or nucleoside analog treated (HBeAg+/NUC) participants with chronic hepatitis B
|
ARO-HBV 200 mg, Q7D
n=4 participants at risk
ARO-HBV 200 mg sc injection Q7D in participants with chronic hepatitis B
|
ARO-HBV 300 mg, Q7D
n=4 participants at risk
ARO-HBV 300 mg sc injection Q7D in participants with chronic hepatitis B
|
ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg
n=12 participants at risk
ARO-HBV 200 mg sc injection Q28D plus JNJ-56136379 250 mg in participants with chronic hepatitis B
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
10.0%
1/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
50.0%
2/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
50.0%
2/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
50.0%
2/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
20.0%
2/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
37.5%
3/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Infections and infestations
Laryngitis
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
10.0%
1/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
50.0%
2/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
10.0%
1/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
10.0%
1/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
General disorders
Chest pain
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
10.0%
1/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
General disorders
Fatigue
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
50.0%
2/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
10.0%
1/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
General disorders
Feeling hot
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
10.0%
1/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
General disorders
Ill-defined disorder
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
2/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
2/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
General disorders
Injection site bruising
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
General disorders
Injection site pain
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
General disorders
Malaise
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
10.0%
1/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
General disorders
Pyrexia
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Infections and infestations
Rhinitis
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Infections and infestations
Tooth infection
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
10.0%
1/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
20.0%
2/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
37.5%
3/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
37.5%
3/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
2/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
50.0%
4/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
75.0%
3/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
16.7%
2/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
10.0%
1/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Injury, poisoning and procedural complications
Vascular access site bruising
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Injury, poisoning and procedural complications
Vascular access site inflammation
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Injury, poisoning and procedural complications
Vascular access site pain
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
10.0%
1/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Injury, poisoning and procedural complications
Vessel puncture site bruise
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
10.0%
1/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
10.0%
1/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
10.0%
1/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
10.0%
1/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Nervous system disorders
Lethargy
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
10.0%
1/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Nervous system disorders
Vertigo
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
10.0%
1/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
2/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
10.0%
1/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Vascular disorders
Hot flush
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Eye disorders
Eye irritation
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Eye disorders
Eye pruritus
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Eye disorders
Visual impairment
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Gastrointestinal disorders
Oral hyperaesthesia
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
General disorders
Asthenia
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
General disorders
Feeling cold
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
General disorders
Flushing
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
General disorders
Injection site discolouration
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
General disorders
Injection site erythema
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
2/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
General disorders
Injection site haematoma
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
General disorders
Nodule
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
General disorders
Temperature intolerance
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Injury, poisoning and procedural complications
Thermal burn
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Eye disorders
Blepharitis
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Eye disorders
Eye swelling
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Eye disorders
Posterior capsule opacification
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
General disorders
Chest discomfort
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
50.0%
2/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Investigations
Crystal urine present
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Investigations
Hepatitis C antibody positive
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Investigations
Liver function test abnormal
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Investigations
Transaminases increased
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Investigations
Urine uric acid increased
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
8.3%
1/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic granuloma
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Psychiatric disorders
Major depression
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
2/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
12.5%
1/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
8.3%
1/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Ear and labyrinth disorders
Ear swelling
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Gastrointestinal disorders
Retroperitoneal mass
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
8.3%
1/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
General disorders
Injection site rash
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Infections and infestations
Influenza
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Investigations
Blood pressure increased
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
8.3%
1/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
50.0%
2/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/10 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/8 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
25.0%
1/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/4 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
0.00%
0/12 • From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
|
Additional Information
Chief Operating Officer
Arrowhead Pharmaceuticals, Inc.
Phone: 626-304-3400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor retains first right to publish results for this multi-center study, and thereafter can review results communications prior to release and can embargo communications regarding trial results for a period that is 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication of results but can require removal of its confidential information (excluding results).
- Publication restrictions are in place
Restriction type: OTHER