Trial Outcomes & Findings for Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency (NCT NCT02616562)
NCT ID: NCT02616562
Last Updated: 2026-01-16
Results Overview
Height velocity (HV) was derived from height measurements taken at baseline (week 0) and the week 26 as: HV = (height at 26 weeks visit- height at baseline) / (time from baseline to 26 weeks visit in years).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
76 participants
Primary outcome timeframe
Baseline (week 0), week 26
Results posted on
2026-01-16
Participant Flow
The trial was conducted at 30 sites in 11 countries.
The study has 3 cohorts. Cohort I participants were randomised (1:1:1:1) to receive norditropin/somapacitan(0.04/0.08/0.16 mg/kg) until week 52. After week 52, participants who were randomised to somapacitan were allocated to open labelled somapacitan and those who randomised to norditropin received same treatment. After week 156, all cohort I participants received somapacitan until August 24. Participants in cohorts II and III were given somapacitan from enrolment (week 156) until August 24.
Participant milestones
| Measure |
Main - Cohort I Norditropin 0.034 mg/kg
Participants received norditropin 0.034 milligram per kilogram (mg/kg) subcutaneously daily during (26 week) main trial period.
|
Main - Cohort I Somapacitan 0.04 mg/kg
Participants received somapacitan 0.04 mg/kg subcutaneously once-weekly during the (26 week) main trial period.
|
Main - Cohort I Somapacitan 0.08 mg/kg
Participants received somapacitan 0.08 mg/kg subcutaneously once- weekly during (26 week) main trial period.
|
Main - Cohort Somapacitan 0.16 mg/kg
Participants received somapacitan 0.16 mg/kg subcutaneously once- weekly during (26 week) main trial period.
|
Extension - Cohort I Norditropin 0.034 mg/kg
Participants received norditropin 0.034 mg/kg subcutaneously daily during (26 week) extension trial period.
|
Extension - Cohort I Somapacitan 0.04 mg/kg
Participants received 0.04 mg/kg subcutaneously once-weekly during the (26 week) extension trial period.
|
Extension - Cohort I Somapacitan 0.08 mg/kg
Participants received 0.08 mg/kg subcutaneously once-weekly during the (26 week) extension trial period.
|
Extension - Cohort I Somapacitan 0.16 mg/kg
Participants received 0.16 mg/kg subcutaneously once-weekly during the (26 week) extension trial period.
|
Safety Extension - Cohort I Norditropin 0.034 mg/kg
Participants randomised to norditropin 0.034 mg/kg continued same treatment subcutaneously daily during (104 week) safety extension period.
|
Safety Extension - Cohort I Somapacitan 0.16 mg/kg
Participants initially randomized to double-blinded somapacitan treatment (0.04/0.08/0.16 mg/kg) during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104 week safety extension period.
|
Long Term Safety Extension - Cohort I Norditropin/Somapacitan
Participants who received norditropin until week 156 were given somapacitan 0.16 mg/kg subcutaneously once weekly for the 208-week long term safety extension period (up till week 364)
|
Long Term Safety Extension - Cohort I Somapacitan 0.16 mg/kg
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly for the 208-week long term safety extension period (up till week 364)
|
Long Term Safety Extension - Cohort II Somapacitan Previously Treated
Participant who was previously treated with GH (Growth hormone) prior to enrollment in the trial at week 156, received somapacitan 0.16 mg/kg subcutaneously once weekly until it was available for prescription in participants' respective countries or until August 2024, at the latest.
|
Long Term Safety Extension - Cohort III Somapacitan Treatment Naive
Participants who were naive to treatment with GH prior to enrollment in the trial at week 156, received open-labelled somapacitan 0.16 mg/kg subcutaneously once weekly until it was available for prescription in participants' respective countries or until August 2024, at the latest.
|
Long Term Safety Extension - Cohort III Somapacitan Previously Treated
Participants who were previously treated with GH prior to enrollment in the trial at week 156, received open-labelled somapacitan 0.16 mg/kg subcutaneously once weekly until it was available for prescription in participants' respective countries or until August 2024, at the latest.
|
Extension After Week 364 - Cohort I Norditropin/Somapacitan
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly until somapacitan was available for prescription for children with GHD in their country or until August 2024, at the latest.
|
Extension After Week 364 - Cohort I Somapacitan 0.16 mg/kg
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly until somapacitan was available for prescription for children with GHD in their country or until August 2024, at the latest.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Main Period (26 Weeks)
COMPLETED
|
14
|
15
|
15
|
14
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Main Period (26 Weeks)
STARTED
|
14
|
16
|
15
|
14
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Main Period (26 Weeks)
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Extension Period (26 Weeks)
STARTED
|
0
|
0
|
0
|
0
|
14
|
15
|
15
|
14
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Extension Period (26 Weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
14
|
15
|
15
|
14
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Extension Period (26 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Safety Extension Period (104 Weeks)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
14
|
44
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Safety Extension Period (104 Weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
12
|
41
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Safety Extension Period (104 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Long Term Safety Extension (208 Weeks)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
12
|
41
|
1
|
4
|
12
|
0
|
0
|
|
Long Term Safety Extension (208 Weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
10
|
33
|
1
|
2
|
9
|
0
|
0
|
|
Long Term Safety Extension (208 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
8
|
0
|
2
|
3
|
0
|
0
|
|
Extension After Week 364 (78 Weeks)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
10
|
33
|
|
Extension After Week 364 (78 Weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
17
|
|
Extension After Week 364 (78 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
16
|
Reasons for withdrawal
| Measure |
Main - Cohort I Norditropin 0.034 mg/kg
Participants received norditropin 0.034 milligram per kilogram (mg/kg) subcutaneously daily during (26 week) main trial period.
|
Main - Cohort I Somapacitan 0.04 mg/kg
Participants received somapacitan 0.04 mg/kg subcutaneously once-weekly during the (26 week) main trial period.
|
Main - Cohort I Somapacitan 0.08 mg/kg
Participants received somapacitan 0.08 mg/kg subcutaneously once- weekly during (26 week) main trial period.
|
Main - Cohort Somapacitan 0.16 mg/kg
Participants received somapacitan 0.16 mg/kg subcutaneously once- weekly during (26 week) main trial period.
|
Extension - Cohort I Norditropin 0.034 mg/kg
Participants received norditropin 0.034 mg/kg subcutaneously daily during (26 week) extension trial period.
|
Extension - Cohort I Somapacitan 0.04 mg/kg
Participants received 0.04 mg/kg subcutaneously once-weekly during the (26 week) extension trial period.
|
Extension - Cohort I Somapacitan 0.08 mg/kg
Participants received 0.08 mg/kg subcutaneously once-weekly during the (26 week) extension trial period.
|
Extension - Cohort I Somapacitan 0.16 mg/kg
Participants received 0.16 mg/kg subcutaneously once-weekly during the (26 week) extension trial period.
|
Safety Extension - Cohort I Norditropin 0.034 mg/kg
Participants randomised to norditropin 0.034 mg/kg continued same treatment subcutaneously daily during (104 week) safety extension period.
|
Safety Extension - Cohort I Somapacitan 0.16 mg/kg
Participants initially randomized to double-blinded somapacitan treatment (0.04/0.08/0.16 mg/kg) during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104 week safety extension period.
|
Long Term Safety Extension - Cohort I Norditropin/Somapacitan
Participants who received norditropin until week 156 were given somapacitan 0.16 mg/kg subcutaneously once weekly for the 208-week long term safety extension period (up till week 364)
|
Long Term Safety Extension - Cohort I Somapacitan 0.16 mg/kg
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly for the 208-week long term safety extension period (up till week 364)
|
Long Term Safety Extension - Cohort II Somapacitan Previously Treated
Participant who was previously treated with GH (Growth hormone) prior to enrollment in the trial at week 156, received somapacitan 0.16 mg/kg subcutaneously once weekly until it was available for prescription in participants' respective countries or until August 2024, at the latest.
|
Long Term Safety Extension - Cohort III Somapacitan Treatment Naive
Participants who were naive to treatment with GH prior to enrollment in the trial at week 156, received open-labelled somapacitan 0.16 mg/kg subcutaneously once weekly until it was available for prescription in participants' respective countries or until August 2024, at the latest.
|
Long Term Safety Extension - Cohort III Somapacitan Previously Treated
Participants who were previously treated with GH prior to enrollment in the trial at week 156, received open-labelled somapacitan 0.16 mg/kg subcutaneously once weekly until it was available for prescription in participants' respective countries or until August 2024, at the latest.
|
Extension After Week 364 - Cohort I Norditropin/Somapacitan
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly until somapacitan was available for prescription for children with GHD in their country or until August 2024, at the latest.
|
Extension After Week 364 - Cohort I Somapacitan 0.16 mg/kg
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly until somapacitan was available for prescription for children with GHD in their country or until August 2024, at the latest.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Main Period (26 Weeks)
Withdrawal by parent/guardian
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Safety Extension Period (104 Weeks)
Withdrawal by parent/guardian
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Safety Extension Period (104 Weeks)
treatment discontinued before visit 5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Safety Extension Period (104 Weeks)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Safety Extension Period (104 Weeks)
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Long Term Safety Extension (208 Weeks)
Withdrawal by parent/guardian
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
0
|
0
|
1
|
0
|
0
|
|
Long Term Safety Extension (208 Weeks)
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Long Term Safety Extension (208 Weeks)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Long Term Safety Extension (208 Weeks)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Long Term Safety Extension (208 Weeks)
Growth velocity in 9 months is 1 cm (1.3 CM/Y)
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Long Term Safety Extension (208 Weeks)
Subject was discontinued from trial
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Long Term Safety Extension (208 Weeks)
Principal Investigator's decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Long Term Safety Extension (208 Weeks)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Long Term Safety Extension (208 Weeks)
Adult height reached
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Extension After Week 364 (78 Weeks)
Somapacitan available in their country
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
16
|
Baseline Characteristics
Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency
Baseline characteristics by cohort
| Measure |
Cohort I Norditropin/Somapacitan
n=14 Participants
Participants received norditropin 0.034 mg/kg subcutaneously daily in main trial period, extension trial period and safety extension trial period. After completing the safety extension trial period (week 156), participants who received norditropin were allocated to open-labelled somapacitan 0.16 mg/kg subcutaneously once weekly for the 104-week safety extension trial period, the 208-week (up till week 364) long-term safety extension period and extension after week 364 period until somapacitan was available for prescription for children with GHD in their country or until August 2024, at the latest.
|
Cohort I Somapacitan 0.04 mg/kg
n=16 Participants
Participants received somapacitan 0.04 mg/kg subcutaneously once-weekly during the 26-week main trial period and the 26-week extension trial period. After completing the main and extension trial periods (week 52), participants received open-labelled somapacitan 0.16 mg/kg/week subcutaneously for the 104-week safety extension trial period, the 208-week (up till week 364) long-term safety extension period and extension after week 364 period until somapacitan was available for prescription for children with GHD in their country or until August 2024, at the latest.
|
Cohort I Somapacitan 0.08 mg/kg
n=15 Participants
Participants received somapacitan 0.08 mg/kg subcutaneously once-weekly during the 26-week main trial period and the 26-week extension trial period. After completing the main and extension trial periods (week 52), participants received open-labelled somapacitan 0.16 mg/kg/week subcutaneously for the 104-week safety extension trial period, the 208-week (up till week 364) long-term safety extension period and extension after week 364 period until somapacitan was available for prescription for children with GHD in their country or until August 2024, at the latest.
|
Cohort I Somapacitan 0.16 mg/kg
n=14 Participants
Participants received somapacitan 0.16 mg/kg subcutaneously once-weekly during the 26-week main trial period and the 26-week extension trial period. After completing the main and extension trial periods (week 52), participants received open-labelled somapacitan 0.16 mg/kg/week subcutaneously for the 104-week safety extension trial period, the 208-week (up till week 364) long-term safety extension period and extension after week 364 period until somapacitan was available for prescription for children with GHD in their country or until August 2024, at the latest.
|
Cohort II Somapacitan Previously Treated
n=1 Participants
Participant who was previously treated with GH prior to enrollment in the trial at week 156, received somapacitan 0.16 mg/kg subcutaneously once weekly until it was available for prescription in participants' respective countries or until August 2024, at the latest.
|
Cohort III Somapacitan Treatment Naive
n=4 Participants
Participants who were naive to treatment with GH prior to enrollment in the trial at week 156, received open-labelled somapacitan 0.16 mg/kg subcutaneously once weekly until it was available for prescription in participants' respective countries or until August 2024, at the latest.
|
Cohort III Somapacitan Previously Treated
n=12 Participants
Participants who were previously treated with GH prior to enrollment in the trial at week 156, received open-labelled somapacitan 0.16 mg/kg subcutaneously once weekly until it was available for prescription in participants' respective countries or until August 2024, at the latest.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
5.89 Years
STANDARD_DEVIATION 1.98 • n=9 Participants
|
5.61 Years
STANDARD_DEVIATION 1.81 • n=6 Participants
|
5.82 Years
STANDARD_DEVIATION 1.82 • n=9 Participants
|
6.06 Years
STANDARD_DEVIATION 2.32 • n=17 Participants
|
2.5 Years
STANDARD_DEVIATION 0.0 • n=16 Participants
|
12.93 Years
STANDARD_DEVIATION 2.24 • n=82 Participants
|
12.69 Years
STANDARD_DEVIATION 2.02 • n=13 Participants
|
7.25 Years
STANDARD_DEVIATION 3.47 • n=335 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=9 Participants
|
7 Participants
n=6 Participants
|
5 Participants
n=9 Participants
|
6 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=82 Participants
|
1 Participants
n=13 Participants
|
25 Participants
n=335 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=9 Participants
|
9 Participants
n=6 Participants
|
10 Participants
n=9 Participants
|
8 Participants
n=17 Participants
|
1 Participants
n=16 Participants
|
3 Participants
n=82 Participants
|
11 Participants
n=13 Participants
|
51 Participants
n=335 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
1 Participants
n=13 Participants
|
2 Participants
n=335 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=9 Participants
|
15 Participants
n=6 Participants
|
15 Participants
n=9 Participants
|
14 Participants
n=17 Participants
|
1 Participants
n=16 Participants
|
4 Participants
n=82 Participants
|
11 Participants
n=13 Participants
|
74 Participants
n=335 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=9 Participants
|
8 Participants
n=6 Participants
|
6 Participants
n=9 Participants
|
8 Participants
n=17 Participants
|
1 Participants
n=16 Participants
|
1 Participants
n=82 Participants
|
3 Participants
n=13 Participants
|
33 Participants
n=335 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=335 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=9 Participants
|
8 Participants
n=6 Participants
|
9 Participants
n=9 Participants
|
6 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
3 Participants
n=82 Participants
|
9 Participants
n=13 Participants
|
42 Participants
n=335 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
PRIMARY outcome
Timeframe: Baseline (week 0), week 26Population: FAS was used to analyse this outcome measure. FAS is defined as all randomized participants that received at least one dose of randomized treatment. Here, Overall number of participants analysed = participants with available data for this outcome measure.
Height velocity (HV) was derived from height measurements taken at baseline (week 0) and the week 26 as: HV = (height at 26 weeks visit- height at baseline) / (time from baseline to 26 weeks visit in years).
Outcome measures
| Measure |
Cohort I - Somapacitan 0.04 mg/kg
n=14 Participants
Participants received somapacitan 0.04 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Somapacitan 0.08 mg/kg
n=15 Participants
Participants received somapacitan 0.08 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Somapcitan 0.16 mg/kg
n=14 Participants
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Norditropin 0.034 mg/kg
n=14 Participants
Participants received norditropin 0.034 mg/kg subcutaneously daily during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I Somapacitan 0.16 mg/kg Week 156 - 364
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly for the 208-week long term safety extension period (up till week 364)
|
Cohort I Somapacitan 0.16 mg/kg Week 0-52
Participants received 0.16 mg/kg subcutaneously once-weekly during the 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.04 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.04 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.08 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.08 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.16 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.16 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Height Velocity (HV) (cm/Year) During the First 26 Weeks of Treatment, Measured as Standing Height With Stadiometer
|
7.96 Centimetre per year (Cm/year)
Standard Deviation 2.04
|
10.92 Centimetre per year (Cm/year)
Standard Deviation 1.90
|
12.88 Centimetre per year (Cm/year)
Standard Deviation 3.46
|
11.35 Centimetre per year (Cm/year)
Standard Deviation 3.27
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From week 156 up to week 364Population: The outcome measure was assessed only for Cohort II and Cohort III. All participants: all adverse events (AEs) with an onset after the first administration of trial product \& up until 14 days after last trial drug administration for withdrawn participants, \& with an onset after the first administration of trial product \& up until visit 32 (week 208) or 14 days after last trial drug administration, which ever comes first for all participants are included in the analysis.
This primary outcome measure was analysed by cohort using descriptive statistics. Adverse event per 100 patient years are presented in this outcome measure.
Outcome measures
| Measure |
Cohort I - Somapacitan 0.04 mg/kg
n=4 Participants
Participants received somapacitan 0.04 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Somapacitan 0.08 mg/kg
n=12 Participants
Participants received somapacitan 0.08 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Somapcitan 0.16 mg/kg
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Norditropin 0.034 mg/kg
n=1 Participants
Participants received norditropin 0.034 mg/kg subcutaneously daily during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I Somapacitan 0.16 mg/kg Week 156 - 364
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly for the 208-week long term safety extension period (up till week 364)
|
Cohort I Somapacitan 0.16 mg/kg Week 0-52
Participants received 0.16 mg/kg subcutaneously once-weekly during the 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.04 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.04 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.08 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.08 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.16 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.16 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort II and Cohort III - Adverse Events Rate, Including Injection Site Reactions in Children With GHD.
|
115.4 Events per 100 patient years
|
196.9 Events per 100 patient years
|
—
|
1047 Events per 100 patient years
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0), week 26, week 52Population: This outcome measure was assessed only for Cohort 1 and FAS was used to analyse this outcome measure. FAS is defined as all randomised participants that received at least one dose of randomised treatment. Here, Overall number of participants analysed = participants with available data for this outcome measure.
Change in height standard deviation score is presented from baseline (week 0) to end of the main trial period week 26 and end of extension trial period week 52. The formula to calculate HSDS is: HSDS = ((Height / M)\*\*L-1) / (L\*S). L: The gender and age-specific power in the Box-Cox transformation, M: The gender and age-specific median, S: The gender and age-specific generalized coefficient of variation. The range for HSDS was -10 to +10. Negative scores indicated a height below the mean height for a child with the same age and gender, whereas positive scores indicated a height above the mean height for a child with the same age and gender.
Outcome measures
| Measure |
Cohort I - Somapacitan 0.04 mg/kg
n=14 Participants
Participants received somapacitan 0.04 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Somapacitan 0.08 mg/kg
n=15 Participants
Participants received somapacitan 0.08 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Somapcitan 0.16 mg/kg
n=14 Participants
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Norditropin 0.034 mg/kg
n=14 Participants
Participants received norditropin 0.034 mg/kg subcutaneously daily during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I Somapacitan 0.16 mg/kg Week 156 - 364
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly for the 208-week long term safety extension period (up till week 364)
|
Cohort I Somapacitan 0.16 mg/kg Week 0-52
Participants received 0.16 mg/kg subcutaneously once-weekly during the 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.04 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.04 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.08 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.08 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.16 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.16 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort I: Change in Height Standard Deviation Score (HSDS)
Change at week 26
|
0.31 Score on scale
Standard Deviation 0.29
|
0.63 Score on scale
Standard Deviation 0.29
|
0.89 Score on scale
Standard Deviation 0.51
|
0.66 Score on scale
Standard Deviation 0.38
|
—
|
—
|
—
|
—
|
—
|
|
Cohort I: Change in Height Standard Deviation Score (HSDS)
Change at week 52
|
0.59 Score on scale
Standard Deviation 0.46
|
0.95 Score on scale
Standard Deviation 0.48
|
1.45 Score on scale
Standard Deviation 0.86
|
0.98 Score on scale
Standard Deviation 0.50
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0), week 26, week 52Population: This outcome measure was assessed only for Cohort 1 and FAS was used to analyse this outcome measure. FAS is defined as all randomised participants that received at least one dose of randomised treatment. Here, Overall number of participants analysed = participants with available data for this outcome measure.
Change in height velocity standard deviation score is presented from baseline (week 0) to end of main trial period week 26 and end of extension trial period week 52. HVSDS was calculated using the formula: HVSDS = (height velocity - mean)/standard deviation (SD), where height velocity was the height velocity variable measured, mean and SD of height velocity by gender and age for the reference population. The range for HVSDS was -10 to +10. Negative scores indicated a height velocity below the mean height velocity for a child with the same age and gender, whereas positive scores indicated a height velocity above the mean height velocity for a child with the same age and gender.
Outcome measures
| Measure |
Cohort I - Somapacitan 0.04 mg/kg
n=14 Participants
Participants received somapacitan 0.04 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Somapacitan 0.08 mg/kg
n=15 Participants
Participants received somapacitan 0.08 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Somapcitan 0.16 mg/kg
n=14 Participants
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Norditropin 0.034 mg/kg
n=14 Participants
Participants received norditropin 0.034 mg/kg subcutaneously daily during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I Somapacitan 0.16 mg/kg Week 156 - 364
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly for the 208-week long term safety extension period (up till week 364)
|
Cohort I Somapacitan 0.16 mg/kg Week 0-52
Participants received 0.16 mg/kg subcutaneously once-weekly during the 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.04 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.04 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.08 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.08 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.16 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.16 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort I: Change in Height Velocity Standard Deviation Score (HVSDS)
Change at week 26
|
4.93 Score on scale
Standard Deviation 3.25
|
7.27 Score on scale
Standard Deviation 3.76
|
10.01 Score on scale
Standard Deviation 4.67
|
9.02 Score on scale
Standard Deviation 5.03
|
—
|
—
|
—
|
—
|
—
|
|
Cohort I: Change in Height Velocity Standard Deviation Score (HVSDS)
Change at week 52
|
4.72 Score on scale
Standard Deviation 2.79
|
6.14 Score on scale
Standard Deviation 3.36
|
8.60 Score on scale
Standard Deviation 3.15
|
7.41 Score on scale
Standard Deviation 4.08
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From week 0 Up to week 364Population: Safety analysis set (SAS) is defined as all randomised participants that received at least one dose of randomised treatment. Data for 3 somapacitan arms (0.04/0.08/0.16 mg/kg) have been pooled from week 156-364, because it was considered appropriate to pool the data from those arms since the size of each individual cohort was small and it would give a more robust measure of long-term safety and tolerability of treatment with somapacitan 0.16 mg/kg/week using this methodology.
Adverse events per 100 patient years are presented. AEs with an onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up until visit 32 (week 364) or 14 days after last trial drug administration, which ever comes first, for all other participants, are analysed.
Outcome measures
| Measure |
Cohort I - Somapacitan 0.04 mg/kg
n=11 Participants
Participants received somapacitan 0.04 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Somapacitan 0.08 mg/kg
n=16 Participants
Participants received somapacitan 0.08 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Somapcitan 0.16 mg/kg
n=15 Participants
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Norditropin 0.034 mg/kg
n=14 Participants
Participants received norditropin 0.034 mg/kg subcutaneously daily during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I Somapacitan 0.16 mg/kg Week 156 - 364
n=39 Participants
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly for the 208-week long term safety extension period (up till week 364)
|
Cohort I Somapacitan 0.16 mg/kg Week 0-52
n=14 Participants
Participants received 0.16 mg/kg subcutaneously once-weekly during the 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.04 mg/kg) Week 52-156
n=15 Participants
Participants initially randomized to double-blinded somapacitan treatment 0.04 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.08 mg/kg) Week 52-156
n=15 Participants
Participants initially randomized to double-blinded somapacitan treatment 0.08 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.16 mg/kg) Week 52-156
n=14 Participants
Participants initially randomized to double-blinded somapacitan treatment 0.16 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort I: Adverse Events Rate, Including Injection Site Reactions
|
116.3 Events per 100 patient years
|
210.4 Events per 100 patient years
|
311.5 Events per 100 patient years
|
247.7 Events per 100 patient years
|
186.3 Events per 100 patient years
|
364.8 Events per 100 patient years
|
163.1 Events per 100 patient years
|
281.2 Events per 100 patient years
|
264.9 Events per 100 patient years
|
SECONDARY outcome
Timeframe: From week 0 Up to week 364Population: This outcome measure was assessed only for Cohort 1 and SAS was used to analyse this outcome measure. SAS is defined as all randomized participants that received at least one dose of randomized treatment. Participants who were randomised to somapacitan 0.04/0.08/0.16 mg/kg/week) received respective doses from week 0 to week 52. From week 52 to week 364, all randomised participants received open labelled somapacitan 0.16 mg/kg/week.
Participants who developed anti-NNC0195-0092 and anti-hGH antibodies are reported in this outcome measure.
Outcome measures
| Measure |
Cohort I - Somapacitan 0.04 mg/kg
n=16 Participants
Participants received somapacitan 0.04 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Somapacitan 0.08 mg/kg
n=15 Participants
Participants received somapacitan 0.08 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Somapcitan 0.16 mg/kg
n=14 Participants
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Norditropin 0.034 mg/kg
n=14 Participants
Participants received norditropin 0.034 mg/kg subcutaneously daily during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I Somapacitan 0.16 mg/kg Week 156 - 364
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly for the 208-week long term safety extension period (up till week 364)
|
Cohort I Somapacitan 0.16 mg/kg Week 0-52
n=45 Participants
Participants received 0.16 mg/kg subcutaneously once-weekly during the 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.04 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.04 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.08 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.08 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.16 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.16 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort I: Occurrence of Anti-NNC0195-0092 and Anti-hGH Antibodies
Anti-NNC0195-0092 antibody
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
—
|
6 Participants
|
—
|
—
|
—
|
|
Cohort I: Occurrence of Anti-NNC0195-0092 and Anti-hGH Antibodies
Anti-hGH antibody
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: (Week 0), week 26, week 52Population: This outcome measure was assessed only for Cohort 1 and FAS was used to analyse this outcome measure. FAS is defined as all randomised participants that received at least one dose of randomised treatment. Here, Overall number of participants analysed = participants with available data for this outcome measure. Number analysed = participants analysed for specific category for this outcome measure.
Change in IGF-I SDS is presented from baseline (week 0) to end of main trial period week 26 and end of extension period week 52. The range for IGF-I SDS was from -10 to +10. Negative scores indicated a IGF-I below the mean IGF-I for a child with the same age and gender, whereas positive scores indicated a IGF-I above the mean IGF-I for a child with the same age and gender.
Outcome measures
| Measure |
Cohort I - Somapacitan 0.04 mg/kg
n=14 Participants
Participants received somapacitan 0.04 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Somapacitan 0.08 mg/kg
n=14 Participants
Participants received somapacitan 0.08 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Somapcitan 0.16 mg/kg
n=14 Participants
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Norditropin 0.034 mg/kg
n=14 Participants
Participants received norditropin 0.034 mg/kg subcutaneously daily during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I Somapacitan 0.16 mg/kg Week 156 - 364
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly for the 208-week long term safety extension period (up till week 364)
|
Cohort I Somapacitan 0.16 mg/kg Week 0-52
Participants received 0.16 mg/kg subcutaneously once-weekly during the 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.04 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.04 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.08 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.08 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.16 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.16 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in Insulin-like Growth Factor I (IGF-I) Standard Deviation Score (SDS)
Change at week 26
|
0.95 Score on scale
Standard Deviation 0.55
|
1.99 Score on scale
Standard Deviation 1.02
|
3.00 Score on scale
Standard Deviation 1.43
|
1.86 Score on scale
Standard Deviation 0.81
|
—
|
—
|
—
|
—
|
—
|
|
Change in Insulin-like Growth Factor I (IGF-I) Standard Deviation Score (SDS)
Change at week 52
|
0.98 Score on scale
Standard Deviation 0.67
|
2.05 Score on scale
Standard Deviation 1.00
|
3.29 Score on scale
Standard Deviation 1.73
|
1.67 Score on scale
Standard Deviation 1.78
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0), week 26, week 52Population: This outcome measure was assessed only for Cohort 1 and FAS was used to analyse this outcome measure. FAS is defined as all randomised participants that received at least one dose of randomised treatment. Here, Overall number of participants analysed = participants with available data for this outcome measure. Number analysed = participants analysed for specific category for this outcome measure.
Change in IGFBP-3 SDS is presented from baseline (week 0) to end of main trial period week 26 and end of extension trial period week 52. The range for IGFBP-3 SDS was from -10 to +10. Negative scores indicated a IGFBP-3 below the mean IGFBP-3 for a child with the same age and gender, whereas positive scores indicated a IGFBP-3 above the mean IGFBP-3 for a child with the same age and gender.
Outcome measures
| Measure |
Cohort I - Somapacitan 0.04 mg/kg
n=13 Participants
Participants received somapacitan 0.04 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Somapacitan 0.08 mg/kg
n=14 Participants
Participants received somapacitan 0.08 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Somapcitan 0.16 mg/kg
n=14 Participants
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Norditropin 0.034 mg/kg
n=14 Participants
Participants received norditropin 0.034 mg/kg subcutaneously daily during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I Somapacitan 0.16 mg/kg Week 156 - 364
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly for the 208-week long term safety extension period (up till week 364)
|
Cohort I Somapacitan 0.16 mg/kg Week 0-52
Participants received 0.16 mg/kg subcutaneously once-weekly during the 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.04 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.04 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.08 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.08 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.16 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.16 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Standard Deviation Score (SDS)
Change at week 26
|
0.86 Score on scale
Standard Deviation 0.73
|
1.59 Score on scale
Standard Deviation 1.04
|
1.45 Score on scale
Standard Deviation 1.33
|
1.58 Score on scale
Standard Deviation 0.99
|
—
|
—
|
—
|
—
|
—
|
|
Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Standard Deviation Score (SDS)
Change at week 52
|
1.05 Score on scale
Standard Deviation 0.87
|
1.54 Score on scale
Standard Deviation 1.13
|
1.81 Score on scale
Standard Deviation 1.39
|
0.95 Score on scale
Standard Deviation 1.88
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (week 0); week 52Population: This outcome measure was assessed only for Cohort 1 and FAS was used to analyse this outcome measure. FAS is defined as all randomized participants that received at least one dose of randomized treatment. Here, Overall number of participants analysed = participants with available data for this outcome measure.
HV was derived from height measurements taken at baseline (week 0) and the week 52 as: HV = (height at 52 weeks visit-height at baseline) / (time from baseline to 52 weeks visit in years)
Outcome measures
| Measure |
Cohort I - Somapacitan 0.04 mg/kg
n=14 Participants
Participants received somapacitan 0.04 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Somapacitan 0.08 mg/kg
n=15 Participants
Participants received somapacitan 0.08 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Somapcitan 0.16 mg/kg
n=14 Participants
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Norditropin 0.034 mg/kg
n=14 Participants
Participants received norditropin 0.034 mg/kg subcutaneously daily during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I Somapacitan 0.16 mg/kg Week 156 - 364
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly for the 208-week long term safety extension period (up till week 364)
|
Cohort I Somapacitan 0.16 mg/kg Week 0-52
Participants received 0.16 mg/kg subcutaneously once-weekly during the 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.04 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.04 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.08 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.08 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.16 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.16 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Height Velocity (HV) (cm/Year) at Weeks 52 (Derived From Standing Height)
|
7.8 Cm/year
Standard Deviation 1.8
|
9.7 Cm/year
Standard Deviation 1.8
|
11.5 Cm/year
Standard Deviation 2.6
|
9.8 Cm/year
Standard Deviation 2.3
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At week 52Population: This outcome measure was assessed only for Cohort 1 and FAS was used to analyse this outcome measure. FAS is defined as all randomized participants that received at least one dose of randomized treatment. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
The bone age vs. chronological age ratio is presented at week 52. X-Ray of left hand and wrist, central assessed according to Greulich \& Pyle atlas were taken.
Outcome measures
| Measure |
Cohort I - Somapacitan 0.04 mg/kg
n=13 Participants
Participants received somapacitan 0.04 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Somapacitan 0.08 mg/kg
n=15 Participants
Participants received somapacitan 0.08 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Somapcitan 0.16 mg/kg
n=13 Participants
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Norditropin 0.034 mg/kg
n=14 Participants
Participants received norditropin 0.034 mg/kg subcutaneously daily during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I Somapacitan 0.16 mg/kg Week 156 - 364
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly for the 208-week long term safety extension period (up till week 364)
|
Cohort I Somapacitan 0.16 mg/kg Week 0-52
Participants received 0.16 mg/kg subcutaneously once-weekly during the 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.04 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.04 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.08 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.08 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.16 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.16 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Bone Age Progression vs. Chronological Age Ratio
|
0.570 Ratio
Standard Deviation 0.147
|
0.651 Ratio
Standard Deviation 0.176
|
0.705 Ratio
Standard Deviation 0.207
|
0.577 Ratio
Standard Deviation 0.176
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At week 52Population: This outcome measure was assessed only for Cohort 1 and FAS was used to analyse this outcome measure. FAS is defined as all randomized participants that received at least one dose of randomized treatment. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
Serum somapacitan concentrations are presented at week 52.
Outcome measures
| Measure |
Cohort I - Somapacitan 0.04 mg/kg
n=14 Participants
Participants received somapacitan 0.04 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Somapacitan 0.08 mg/kg
n=14 Participants
Participants received somapacitan 0.08 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Somapcitan 0.16 mg/kg
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Norditropin 0.034 mg/kg
n=14 Participants
Participants received norditropin 0.034 mg/kg subcutaneously daily during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I Somapacitan 0.16 mg/kg Week 156 - 364
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly for the 208-week long term safety extension period (up till week 364)
|
Cohort I Somapacitan 0.16 mg/kg Week 0-52
Participants received 0.16 mg/kg subcutaneously once-weekly during the 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.04 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.04 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.08 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.08 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.16 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.16 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Serum Somapacitan Concentrations
|
44.563 Ng/mL
Standard Deviation 60.922
|
169.320 Ng/mL
Standard Deviation 212.233
|
—
|
18.381 Ng/mL
Standard Deviation 20.911
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0), week 26, week 52Population: This outcome measure was assessed only for Cohort 1 and FAS was used to analyse this outcome measure. FAS is defined as all randomized participants that received at least one dose of randomized treatment. Here, Overall number of participants analysed = participants with available data for this outcome measure. Number analysed = participants analysed for specific category for this outcome measure.
Change in Treatment Related Impact Measure from baseline (week 0) to week 26 and week 52 were assessed in children with growth hormone deficiency. This outcome measure was assessed using patient reported outcome (PRO) questionnaires with 3 domains, such as emotional well-being score, physical health score, social wellbeing core and total score. The total score was calculated by taking average of each domain. The scale range for each domain and total score was from 0-100 and a lower score indicates a better health state. TRIMCGHD-O was analysed using descriptive statistics.
Outcome measures
| Measure |
Cohort I - Somapacitan 0.04 mg/kg
n=14 Participants
Participants received somapacitan 0.04 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Somapacitan 0.08 mg/kg
n=15 Participants
Participants received somapacitan 0.08 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Somapcitan 0.16 mg/kg
n=14 Participants
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Norditropin 0.034 mg/kg
n=14 Participants
Participants received norditropin 0.034 mg/kg subcutaneously daily during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I Somapacitan 0.16 mg/kg Week 156 - 364
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly for the 208-week long term safety extension period (up till week 364)
|
Cohort I Somapacitan 0.16 mg/kg Week 0-52
Participants received 0.16 mg/kg subcutaneously once-weekly during the 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.04 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.04 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.08 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.08 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.16 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.16 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Changes in Emotional Well-being Score, Physical Health Score, Social Well-being Score and Total Score in TRIM-CGHD-O (Treatment Related Impact Measure - Child Growth Hormone Deficiency- Observer)
Social well-being score at week 26
|
0.6 Score on scale
Standard Deviation 20.3
|
-8.6 Score on scale
Standard Deviation 17.8
|
-11.0 Score on scale
Standard Deviation 22.7
|
-9.6 Score on scale
Standard Deviation 17.5
|
—
|
—
|
—
|
—
|
—
|
|
Changes in Emotional Well-being Score, Physical Health Score, Social Well-being Score and Total Score in TRIM-CGHD-O (Treatment Related Impact Measure - Child Growth Hormone Deficiency- Observer)
Physical health score at week 26
|
-4.0 Score on scale
Standard Deviation 10.3
|
-2.8 Score on scale
Standard Deviation 27.0
|
-11.6 Score on scale
Standard Deviation 16.9
|
4.3 Score on scale
Standard Deviation 18.8
|
—
|
—
|
—
|
—
|
—
|
|
Changes in Emotional Well-being Score, Physical Health Score, Social Well-being Score and Total Score in TRIM-CGHD-O (Treatment Related Impact Measure - Child Growth Hormone Deficiency- Observer)
Physical health score at week 52
|
0.9 Score on scale
Standard Deviation 13.8
|
-1.0 Score on scale
Standard Deviation 20.9
|
-6.7 Score on scale
Standard Deviation 16.8
|
-1.9 Score on scale
Standard Deviation 13.4
|
—
|
—
|
—
|
—
|
—
|
|
Changes in Emotional Well-being Score, Physical Health Score, Social Well-being Score and Total Score in TRIM-CGHD-O (Treatment Related Impact Measure - Child Growth Hormone Deficiency- Observer)
Emotional well-being score at week 26
|
1.0 Score on scale
Standard Deviation 24.9
|
1.1 Score on scale
Standard Deviation 22.0
|
2.4 Score on scale
Standard Deviation 28.4
|
-3.3 Score on scale
Standard Deviation 19.8
|
—
|
—
|
—
|
—
|
—
|
|
Changes in Emotional Well-being Score, Physical Health Score, Social Well-being Score and Total Score in TRIM-CGHD-O (Treatment Related Impact Measure - Child Growth Hormone Deficiency- Observer)
Emotional well-being score at week 52
|
1.4 Score on scale
Standard Deviation 18.7
|
-8.0 Score on scale
Standard Deviation 22.7
|
-12.2 Score on scale
Standard Deviation 27.9
|
-5.7 Score on scale
Standard Deviation 13.2
|
—
|
—
|
—
|
—
|
—
|
|
Changes in Emotional Well-being Score, Physical Health Score, Social Well-being Score and Total Score in TRIM-CGHD-O (Treatment Related Impact Measure - Child Growth Hormone Deficiency- Observer)
Total score at week 52
|
1.8 Score on scale
Standard Deviation 13.5
|
-9.4 Score on scale
Standard Deviation 17.3
|
-12.7 Score on scale
Standard Deviation 12.3
|
-6.1 Score on scale
Standard Deviation 10.2
|
—
|
—
|
—
|
—
|
—
|
|
Changes in Emotional Well-being Score, Physical Health Score, Social Well-being Score and Total Score in TRIM-CGHD-O (Treatment Related Impact Measure - Child Growth Hormone Deficiency- Observer)
Social well-being score at week 52
|
4.5 Score on scale
Standard Deviation 20.6
|
-20.5 Score on scale
Standard Deviation 20.4
|
-17.9 Score on scale
Standard Deviation 21.2
|
-9.5 Score on scale
Standard Deviation 23.9
|
—
|
—
|
—
|
—
|
—
|
|
Changes in Emotional Well-being Score, Physical Health Score, Social Well-being Score and Total Score in TRIM-CGHD-O (Treatment Related Impact Measure - Child Growth Hormone Deficiency- Observer)
Total score at week 26
|
-0.7 Score on scale
Standard Deviation 13.6
|
-3.9 Score on scale
Standard Deviation 16.4
|
-5.9 Score on scale
Standard Deviation 12.6
|
-4.6 Score on scale
Standard Deviation 10.7
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At week 26, at week 52Population: This outcome measure was assessed only for Cohort 1 and FAS was used to analyse this outcome measure. FAS is defined as all randomized participants that received at least one dose of randomized treatment. Here, Overall number of participants analysed = participants with available data for this outcome measure. Number analysed = participants analysed for specific category for this outcome measure.
Total score of Treatment Burden Measure (observer) was assessed at week 26 and at week 52 in children with growth hormone deficiency. This outcome measure was assessed using PRO questionnaires. The scale range for total score was from 0-100 and a lower score indicates a better health state.
Outcome measures
| Measure |
Cohort I - Somapacitan 0.04 mg/kg
n=14 Participants
Participants received somapacitan 0.04 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Somapacitan 0.08 mg/kg
n=15 Participants
Participants received somapacitan 0.08 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Somapcitan 0.16 mg/kg
n=14 Participants
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Norditropin 0.034 mg/kg
n=12 Participants
Participants received norditropin 0.034 mg/kg subcutaneously daily during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I Somapacitan 0.16 mg/kg Week 156 - 364
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly for the 208-week long term safety extension period (up till week 364)
|
Cohort I Somapacitan 0.16 mg/kg Week 0-52
Participants received 0.16 mg/kg subcutaneously once-weekly during the 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.04 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.04 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.08 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.08 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.16 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.16 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Total Score of TB-CGHD-O (The Treatment Burden Measure - Child Growth Hormone Deficiency - Observer)
Total score at week 52
|
13.7 Score on scale
Standard Deviation 13.2
|
11.3 Score on scale
Standard Deviation 12.3
|
3.9 Score on scale
Standard Deviation 8.1
|
12.3 Score on scale
Standard Deviation 13.9
|
—
|
—
|
—
|
—
|
—
|
|
Total Score of TB-CGHD-O (The Treatment Burden Measure - Child Growth Hormone Deficiency - Observer)
Total score at week 26
|
14.0 Score on scale
Standard Deviation 11.9
|
10.2 Score on scale
Standard Deviation 11.0
|
6.8 Score on scale
Standard Deviation 8.9
|
14.8 Score on scale
Standard Deviation 16.2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At week 26, at week 52Population: This outcome measure was assessed only for Cohort 1 and FAS was used to analyse this outcome measure. FAS is defined as all randomized participants that received at least one dose of randomized treatment. Here, Overall number of participants analysed = participants with available data for this outcome measure. Number analysed = participants analysed for specific category for this outcome measure.
Total score of Treatment Burden Measure (parent/guardian) is reported at week 26 and at week 52 in children with growth hormone deficiency. This outcome measure was assessed using PRO questionnaires. The scale range for total score was from 0-100 and a lower score indicates a better health state.
Outcome measures
| Measure |
Cohort I - Somapacitan 0.04 mg/kg
n=14 Participants
Participants received somapacitan 0.04 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Somapacitan 0.08 mg/kg
n=15 Participants
Participants received somapacitan 0.08 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Somapcitan 0.16 mg/kg
n=14 Participants
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Norditropin 0.034 mg/kg
n=13 Participants
Participants received norditropin 0.034 mg/kg subcutaneously daily during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I Somapacitan 0.16 mg/kg Week 156 - 364
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly for the 208-week long term safety extension period (up till week 364)
|
Cohort I Somapacitan 0.16 mg/kg Week 0-52
Participants received 0.16 mg/kg subcutaneously once-weekly during the 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.04 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.04 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.08 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.08 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
Cohort I Somapacitan 0.16 mg/kg (Previous Dose 0.16 mg/kg) Week 52-156
Participants initially randomized to double-blinded somapacitan treatment 0.16 mg/kg during main and extension period received open-labelled somapacitan 0.16 mg/kg subcutaneously once-weekly during 104-week safety extension period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Total Score of TB-CGHD-P (The Treatment Burden Measure - Child Growth Hormone Deficiency - Parent/Guardian)
Total score at week 26
|
24.6 Score on scale
Standard Deviation 16.7
|
17.5 Score on scale
Standard Deviation 20.5
|
18.8 Score on scale
Standard Deviation 22.2
|
26.9 Score on scale
Standard Deviation 24.7
|
—
|
—
|
—
|
—
|
—
|
|
Total Score of TB-CGHD-P (The Treatment Burden Measure - Child Growth Hormone Deficiency - Parent/Guardian)
Total score at week 52
|
19.6 Score on scale
Standard Deviation 19.0
|
13.8 Score on scale
Standard Deviation 12.5
|
15.6 Score on scale
Standard Deviation 16.6
|
23.6 Score on scale
Standard Deviation 27.3
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort I - Norditropin (Week 0-156)
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Cohort I - Norditropin/Somapacitan 0.16 mg/kg (Week 156-364)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort I - Norditropin/Somapacitan 0.16 mg/kg (Week >364)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort I - Somapacitan 0.04 mg/kg (Week 0-52)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Cohort I - Somapacitan 0.08 mg/kg (Week 0-52)
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Cohort I - Somapacitan 0.16 mg/kg (Week 0-52)
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Cohort I - Somapacitan 0.16 mg/kg (Week 52-442)
Serious events: 6 serious events
Other events: 35 other events
Deaths: 0 deaths
Cohort II - Somapacitan (0.16 mg/kg) Previously Treated
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort III - Somapacitan (0.16 mg/kg) Treatment Naive
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort III - Somapacitan (0.16 mg/kg) Previously Treated
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort I - Norditropin (Week 0-156)
n=14 participants at risk
Participants were randomized to receive norditropin 0.034 mg/kg daily in main trial, extension trial period and open labelled in safety extension trial period.
|
Cohort I - Norditropin/Somapacitan 0.16 mg/kg (Week 156-364)
n=11 participants at risk
After completing the safety extension trial period (week 156), participants who received norditropin were allocated to open-labelled somapacitan 0.16 mg/kg subcutaneously once weekly for the 208-week (up till week 364) long-term safety extension period.
|
Cohort I - Norditropin/Somapacitan 0.16 mg/kg (Week >364)
n=5 participants at risk
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly from week 364 until somapacitan was available for prescription for children with GHD in their country or until August 2024, at the latest.
|
Cohort I - Somapacitan 0.04 mg/kg (Week 0-52)
n=16 participants at risk
Participants received somapacitan 0.04 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Somapacitan 0.08 mg/kg (Week 0-52)
n=15 participants at risk
Participants received somapacitan 0.08 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Somapacitan 0.16 mg/kg (Week 0-52)
n=14 participants at risk
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Somapacitan 0.16 mg/kg (Week 52-442)
n=44 participants at risk
After completing the main and extension trial periods (week 52), participants who were initially randomized to double-blinded somapacitan (0.04/0.08/0.16 mg/kg/week) received open-labelled somapacitan 0.16 mg/kg/week subcutaneously during safety extension trial period, 208-week (up till week 364) long-term safety extension period and until somapacitan was available for prescription for children with GHD in their country or until August 2024, at the latest.
|
Cohort II - Somapacitan (0.16 mg/kg) Previously Treated
n=1 participants at risk
Participant who was previously treated with GH prior to enrollment in the trial at week 156, received somapacitan 0.16 mg/kg subcutaneously once weekly until it was available for prescription in participants' respective countries or until August 2024, at the latest.
|
Cohort III - Somapacitan (0.16 mg/kg) Treatment Naive
n=4 participants at risk
Participants who were naive to treatment with GH prior to enrollment in the trial at week 156, received open-labelled somapacitan 0.16 mg/kg subcutaneously once weekly until it was available for prescription in participants' respective countries or until August 2024, at the latest.
|
Cohort III - Somapacitan (0.16 mg/kg) Previously Treated
n=12 participants at risk
Participants who were previously treated with GH prior to enrollment in the trial at week 156, received open-labelled somapacitan 0.16 mg/kg subcutaneously once weekly until it was available for prescription in participants' respective countries or until August 2024, at the latest.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Surgical and medical procedures
Adenoidectomy
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
2.3%
1/44 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
2.3%
1/44 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
2.3%
1/44 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Epiphysiolysis
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
2.3%
1/44 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.7%
1/15 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
2.3%
1/44 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
General disorders
Generalised oedema
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Endocrine disorders
Hypopituitarism
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.7%
1/15 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Norovirus infection
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
100.0%
1/1 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Respiratory syncytial virus bronchitis
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
100.0%
1/1 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Nervous system disorders
Seizure
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
2.3%
1/44 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
Other adverse events
| Measure |
Cohort I - Norditropin (Week 0-156)
n=14 participants at risk
Participants were randomized to receive norditropin 0.034 mg/kg daily in main trial, extension trial period and open labelled in safety extension trial period.
|
Cohort I - Norditropin/Somapacitan 0.16 mg/kg (Week 156-364)
n=11 participants at risk
After completing the safety extension trial period (week 156), participants who received norditropin were allocated to open-labelled somapacitan 0.16 mg/kg subcutaneously once weekly for the 208-week (up till week 364) long-term safety extension period.
|
Cohort I - Norditropin/Somapacitan 0.16 mg/kg (Week >364)
n=5 participants at risk
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly from week 364 until somapacitan was available for prescription for children with GHD in their country or until August 2024, at the latest.
|
Cohort I - Somapacitan 0.04 mg/kg (Week 0-52)
n=16 participants at risk
Participants received somapacitan 0.04 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Somapacitan 0.08 mg/kg (Week 0-52)
n=15 participants at risk
Participants received somapacitan 0.08 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Somapacitan 0.16 mg/kg (Week 0-52)
n=14 participants at risk
Participants received somapacitan 0.16 mg/kg subcutaneously once weekly during 26 weeks main trial period and 26 weeks extension trial period.
|
Cohort I - Somapacitan 0.16 mg/kg (Week 52-442)
n=44 participants at risk
After completing the main and extension trial periods (week 52), participants who were initially randomized to double-blinded somapacitan (0.04/0.08/0.16 mg/kg/week) received open-labelled somapacitan 0.16 mg/kg/week subcutaneously during safety extension trial period, 208-week (up till week 364) long-term safety extension period and until somapacitan was available for prescription for children with GHD in their country or until August 2024, at the latest.
|
Cohort II - Somapacitan (0.16 mg/kg) Previously Treated
n=1 participants at risk
Participant who was previously treated with GH prior to enrollment in the trial at week 156, received somapacitan 0.16 mg/kg subcutaneously once weekly until it was available for prescription in participants' respective countries or until August 2024, at the latest.
|
Cohort III - Somapacitan (0.16 mg/kg) Treatment Naive
n=4 participants at risk
Participants who were naive to treatment with GH prior to enrollment in the trial at week 156, received open-labelled somapacitan 0.16 mg/kg subcutaneously once weekly until it was available for prescription in participants' respective countries or until August 2024, at the latest.
|
Cohort III - Somapacitan (0.16 mg/kg) Previously Treated
n=12 participants at risk
Participants who were previously treated with GH prior to enrollment in the trial at week 156, received open-labelled somapacitan 0.16 mg/kg subcutaneously once weekly until it was available for prescription in participants' respective countries or until August 2024, at the latest.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.7%
1/15 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.8%
3/44 • Number of events 4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
2.3%
1/44 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
8.3%
1/12 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
2.3%
1/44 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
8.3%
1/12 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Investigations
Alanine aminotransferase increased
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Blood and lymphatic system disorders
Anaemia
|
14.3%
2/14 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.7%
1/15 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
14.3%
2/14 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Eye disorders
Anisometropia
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
9.1%
1/11 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
13.6%
6/44 • Number of events 7 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
8.3%
1/12 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.7%
1/15 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
4.5%
2/44 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.8%
3/44 • Number of events 3 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.2%
1/16 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
4.5%
2/44 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
100.0%
1/1 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.7%
1/15 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
4.5%
2/44 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
8.3%
1/12 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Psychiatric disorders
Autism spectrum disorder
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
8.3%
1/12 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.2%
1/16 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
8.3%
1/12 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Investigations
Blood glucose abnormal
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
9.1%
1/11 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
2.3%
1/44 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Bronchitis
|
14.3%
2/14 • Number of events 3 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
4.5%
2/44 • Number of events 3 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
COVID-19
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
31.8%
14/44 • Number of events 17 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
100.0%
1/1 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
25.0%
1/4 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
25.0%
3/12 • Number of events 4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
9.1%
1/11 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
4.5%
2/44 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
100.0%
1/1 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
9.1%
1/11 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
9.1%
4/44 • Number of events 6 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.2%
1/16 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
13.3%
2/15 • Number of events 3 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
13.6%
6/44 • Number of events 8 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
7.1%
1/14 • Number of events 3 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.8%
3/44 • Number of events 3 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
2/14 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
9.1%
1/11 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.2%
1/16 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.8%
3/44 • Number of events 4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
25.0%
1/4 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Surgical and medical procedures
Cranial operation
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
8.3%
1/12 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Cardiac disorders
Defect conduction intraventricular
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
25.0%
1/4 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
25.0%
1/4 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
4.5%
2/44 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
9.1%
1/11 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
20.0%
1/5 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
100.0%
1/1 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Dermatosis
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
13.3%
2/15 • Number of events 3 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
7.1%
1/14 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
4.5%
2/44 • Number of events 5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
100.0%
1/1 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Nervous system disorders
Disturbance in attention
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
9.1%
1/11 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
9.1%
1/11 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Immune system disorders
Drug hypersensitivity
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Ear infection
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
8.3%
1/12 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
20.0%
1/5 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
11.4%
5/44 • Number of events 6 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
9.1%
1/11 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Social circumstances
Educational problem
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
8.3%
1/12 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.8%
3/44 • Number of events 3 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
25.0%
1/4 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
General disorders
Fatigue
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
50.0%
2/4 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Nervous system disorders
Febrile convulsion
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Immune system disorders
Food allergy
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
2.3%
1/44 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
100.0%
1/1 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
9.1%
1/11 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Hepatobiliary disorders
Gallbladder disorder
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Gastroenteritis
|
14.3%
2/14 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
9.1%
1/11 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.2%
1/16 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
13.6%
6/44 • Number of events 9 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.7%
1/15 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
9.1%
4/44 • Number of events 7 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
8.3%
1/12 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
9.1%
1/11 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
8.3%
1/12 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
8.3%
1/12 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Growing pains
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.8%
3/44 • Number of events 4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
8.3%
1/12 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.8%
3/44 • Number of events 3 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
100.0%
1/1 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
12.5%
2/16 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.7%
1/15 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Nervous system disorders
Headache
|
14.3%
2/14 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
11.4%
5/44 • Number of events 9 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
25.0%
1/4 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
16.7%
2/12 • Number of events 3 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
8.3%
1/12 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
9.1%
1/11 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
2.3%
1/44 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
8.3%
1/12 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Metabolism and nutrition disorders
Impaired fasting glucose
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Impetigo
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.8%
3/44 • Number of events 3 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Influenza
|
21.4%
3/14 • Number of events 4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
9.1%
1/11 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
13.3%
2/15 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
7.1%
1/14 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
20.5%
9/44 • Number of events 14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
100.0%
1/1 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
General disorders
Influenza like illness
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
General disorders
Injection site reaction
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
9.1%
1/11 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
2.3%
1/44 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
General disorders
Malaise
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
9.1%
1/11 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
2.3%
1/44 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Blood and lymphatic system disorders
Microcytosis
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
8.3%
1/12 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Blood and lymphatic system disorders
Monocytosis
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Mumps
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Nasopharyngitis
|
21.4%
3/14 • Number of events 12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
18.2%
2/11 • Number of events 4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.7%
1/15 • Number of events 7 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
21.4%
3/14 • Number of events 8 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
18.2%
8/44 • Number of events 52 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
100.0%
1/1 • Number of events 12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
25.0%
1/4 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
25.0%
3/12 • Number of events 8 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
9.1%
1/11 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
9.1%
4/44 • Number of events 5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
25.0%
1/4 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
8.3%
1/12 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Hepatobiliary disorders
Non-alcoholic fatty liver
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
9.1%
1/11 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Nervous system disorders
Nystagmus
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Eye disorders
Optic nerve cupping
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Oral herpes
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
4.5%
2/44 • Number of events 3 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Otitis media
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.2%
1/16 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
13.3%
2/15 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
13.6%
6/44 • Number of events 8 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
100.0%
1/1 • Number of events 7 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Otitis media acute
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
4.5%
2/44 • Number of events 3 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
100.0%
1/1 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
General disorders
Pain
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
8.3%
1/12 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.2%
1/16 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.7%
1/15 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
4.5%
2/44 • Number of events 3 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
8.3%
1/12 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Paronychia
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.8%
3/44 • Number of events 3 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.7%
1/15 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.8%
3/44 • Number of events 6 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
8.3%
1/12 • Number of events 4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
2.3%
1/44 • Number of events 4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
8.3%
1/12 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Investigations
Platelet count increased
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.2%
1/16 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
2.3%
1/44 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Pyoderma
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
9.1%
1/11 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
General disorders
Pyrexia
|
14.3%
2/14 • Number of events 5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
9.1%
1/11 • Number of events 6 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
37.5%
6/16 • Number of events 8 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.7%
1/15 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
27.3%
12/44 • Number of events 20 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
100.0%
1/1 • Number of events 5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
8.3%
1/12 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.8%
3/44 • Number of events 4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Respiratory tract infection
|
14.3%
2/14 • Number of events 3 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.8%
3/44 • Number of events 7 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Respiratory tract infection viral
|
7.1%
1/14 • Number of events 3 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
18.2%
2/11 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.7%
1/15 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Rhinitis
|
21.4%
3/14 • Number of events 3 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
18.2%
2/11 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
4.5%
2/44 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
21.4%
3/14 • Number of events 3 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
13.6%
6/44 • Number of events 11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Scarlet fever
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Immune system disorders
Seasonal allergy
|
7.1%
1/14 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
9.1%
1/11 • Number of events 3 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.8%
3/44 • Number of events 5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
100.0%
1/1 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
8.3%
1/12 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Seborrhoea
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
8.3%
1/12 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Nervous system disorders
Sensory processing disorder
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
8.3%
1/12 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.2%
1/16 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
4.5%
2/44 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.7%
1/15 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
9.1%
4/44 • Number of events 5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Social circumstances
Social problem
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
8.3%
1/12 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Nervous system disorders
Speech disorder
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Nervous system disorders
Speech disorder developmental
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
7.1%
1/14 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
9.1%
4/44 • Number of events 22 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Eye disorders
Strabismus
|
7.1%
1/14 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
9.1%
1/11 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.7%
1/15 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Eye disorders
Swelling of eyelid
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
2.3%
1/44 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
8.3%
1/12 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
9.1%
1/11 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
General disorders
Temperature intolerance
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
25.0%
1/4 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
12.5%
2/16 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.8%
3/44 • Number of events 3 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Tooth abscess
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Upper respiratory tract infection
|
14.3%
2/14 • Number of events 3 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
20.0%
1/5 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.2%
1/16 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
13.3%
2/15 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
4.5%
2/44 • Number of events 6 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
100.0%
1/1 • Number of events 4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
25.0%
3/12 • Number of events 5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
13.3%
2/15 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
2.3%
1/44 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
100.0%
1/1 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
8.3%
1/12 • Number of events 3 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Varicella
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
9.1%
1/11 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.7%
1/15 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
2.3%
1/44 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
9.1%
1/11 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Viral infection
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
9.1%
1/11 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.2%
1/16 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.8%
3/44 • Number of events 3 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Eye disorders
Visual impairment
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
9.1%
1/11 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
4.5%
2/44 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
8.3%
1/12 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Number of events 4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
18.2%
2/11 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.7%
1/15 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
15.9%
7/44 • Number of events 8 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
25.0%
1/4 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Adenovirus infection
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.7%
1/15 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.7%
1/15 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.2%
1/16 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.2%
1/16 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Dientamoeba infection
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Eye disorders
Dry eye
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Endocrine disorders
Glucocorticoid deficiency
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.7%
1/15 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
2.3%
1/44 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Investigations
Haematology test abnormal
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
14.3%
2/14 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Herpangina
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.7%
1/15 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.2%
1/16 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
General disorders
Injection site haematoma
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.2%
1/16 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
2.3%
1/44 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.7%
1/15 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Lipoatrophy
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
12.5%
2/16 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
7.1%
1/14 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
2.3%
1/44 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.7%
1/15 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.7%
1/15 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Nervous system disorders
Petit mal epilepsy
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.7%
1/15 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
2.3%
1/44 • Number of events 2 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
6.2%
1/16 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/14 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/11 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/5 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/16 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/15 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
7.1%
1/14 • Number of events 1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/44 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/1 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/4 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
0.00%
0/12 • Week 0 to week 442
Cohort I: SAS is defined as all randomised participants that received at least one dose of randomised treatment. Cohort II and III: All participants enrolled in Cohort II and Cohort III. All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent", if the onset of the event occurs in the on-treatment period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee "At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property"
- Publication restrictions are in place
Restriction type: OTHER