Trial Outcomes & Findings for Study to Assess Safety, Tolerability and Efficacy of SC Administered MBL949 in Obese Participants With or Without T2DM (NCT NCT05199090)
NCT ID: NCT05199090
Last Updated: 2024-10-09
Results Overview
Number of participants with adverse events reported after the first dose of study medication or events present prior to treatment but increase in severity
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
126 participants
Primary outcome timeframe
Baseline to Day 169
Results posted on
2024-10-09
Participant Flow
A total of 4 research centers in United States participated in the study.
Participants underwent a screening visit between Day -35 and Day -15 to determine their eligibility for the study. On Day 1, participants went to the clinic after an overnight fast of at least 10 hours to complete the Day 1 assessments prior to dosing.
Participant milestones
| Measure |
MBL949 Arm 1
MBL949 one 3 mg dose followed by two doses of 6 mg followed by five doses of 4.5 mg
|
MBL949 Arm 2
MBL949 two 3 mg doses followed by six doses of 4.5 mg
|
MBL949 Arm 3
MBL949 one 12 mg dose followed by seven doses of 4.5 mg
|
MBL949 Arm 4
MBL949 one 1.5 mg dose followed by seven doses of 2.2 mg
|
MBL949 Arm 5
MBL949 one 3 mg dose followed by two doses of 6 mg followed by five doses of 7.5 mg
|
Placebo
Placebo to MBL949
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
22
|
16
|
15
|
15
|
44
|
|
Overall Study
COMPLETED
|
12
|
8
|
15
|
9
|
10
|
31
|
|
Overall Study
NOT COMPLETED
|
2
|
14
|
1
|
6
|
5
|
13
|
Reasons for withdrawal
| Measure |
MBL949 Arm 1
MBL949 one 3 mg dose followed by two doses of 6 mg followed by five doses of 4.5 mg
|
MBL949 Arm 2
MBL949 two 3 mg doses followed by six doses of 4.5 mg
|
MBL949 Arm 3
MBL949 one 12 mg dose followed by seven doses of 4.5 mg
|
MBL949 Arm 4
MBL949 one 1.5 mg dose followed by seven doses of 2.2 mg
|
MBL949 Arm 5
MBL949 one 3 mg dose followed by two doses of 6 mg followed by five doses of 7.5 mg
|
Placebo
Placebo to MBL949
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
4
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
4
|
0
|
5
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Study terminated by sponsor
|
0
|
6
|
0
|
0
|
0
|
5
|
|
Overall Study
Subject decision
|
0
|
4
|
0
|
2
|
5
|
2
|
Baseline Characteristics
Study to Assess Safety, Tolerability and Efficacy of SC Administered MBL949 in Obese Participants With or Without T2DM
Baseline characteristics by cohort
| Measure |
MBL949 Arm 1
n=14 Participants
MBL949 one 3 mg dose followed by two doses of 6 mg followed by five doses of 4.5 mg
|
MBL949 Arm 2
n=22 Participants
MBL949 two 3 mg doses followed by six doses of 4.5 mg
|
MBL949 Arm 3
n=16 Participants
MBL949 one 12 mg dose followed by seven doses of 4.5 mg
|
MBL949 Arm 4
n=15 Participants
MBL949 one 1.5 mg dose followed by seven doses of 2.2 mg
|
MBL949 Arm 5
n=15 Participants
MBL949 one 3 mg dose followed by two doses of 6 mg followed by five doses of 7.5 mg
|
Placebo
n=44 Participants
Placebo to MBL949
|
Total
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
47.4 years
STANDARD_DEVIATION 9.53 • n=5 Participants
|
45.8 years
STANDARD_DEVIATION 7.77 • n=7 Participants
|
44.8 years
STANDARD_DEVIATION 11.23 • n=5 Participants
|
45.8 years
STANDARD_DEVIATION 8.98 • n=4 Participants
|
41.6 years
STANDARD_DEVIATION 10.68 • n=21 Participants
|
44.0 years
STANDARD_DEVIATION 10.09 • n=10 Participants
|
44.7 years
STANDARD_DEVIATION 9.70 • n=115 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
38 Participants
n=10 Participants
|
101 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
25 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
29 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
White
|
11 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
33 Participants
n=10 Participants
|
97 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 169Population: Safety Set: included all subjects that received any study drug.
Number of participants with adverse events reported after the first dose of study medication or events present prior to treatment but increase in severity
Outcome measures
| Measure |
MBL949 Arm 5
n=15 Participants
MBL949 one 3 mg dose followed by two doses of 6 mg followed by five doses of 7.5 mg
|
Pooled MBL949
n=82 Participants
Pooled MBL949 arms
|
Placebo
n=44 Participants
Placebo to MBL949
|
MBL949 Arm 1
n=14 Participants
MBL949 one 3 mg dose followed by two doses of 6 mg followed by five doses of 4.5 mg
|
MBL949 Arm 2
n=22 Participants
MBL949 two 3 mg doses followed by six doses of 4.5 mg
|
MBL949 Arm 3
n=16 Participants
MBL949 one 12 mg dose followed by seven doses of 4.5 mg
|
MBL949 Arm 4
n=15 Participants
MBL949 one 1.5 mg dose followed by seven doses of 2.2 mg
|
|---|---|---|---|---|---|---|---|
|
Frequency and Severity of Adverse Events
Total AEs
|
14 Participants
|
70 Participants
|
30 Participants
|
11 Participants
|
20 Participants
|
15 Participants
|
10 Participants
|
|
Frequency and Severity of Adverse Events
AEs of mild intensity
|
14 Participants
|
68 Participants
|
29 Participants
|
10 Participants
|
19 Participants
|
15 Participants
|
10 Participants
|
|
Frequency and Severity of Adverse Events
AEs of moderate intensity
|
8 Participants
|
30 Participants
|
7 Participants
|
4 Participants
|
8 Participants
|
7 Participants
|
3 Participants
|
|
Frequency and Severity of Adverse Events
AEs of severe intensity
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Adverse Events
Study drug-related AEs
|
12 Participants
|
62 Participants
|
19 Participants
|
9 Participants
|
18 Participants
|
15 Participants
|
8 Participants
|
|
Frequency and Severity of Adverse Events
Serious AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: PD analysis set: included all subjects who received any study drug, had Pharmacodynamics (PD) data, and had no protocol deviations with relevant impact on PD data. Only participants with weight data at Baseline and Week 16 were included in the analysis.
Baseline weight is defined as the last weight measurement before dosing in kilograms
Outcome measures
| Measure |
MBL949 Arm 5
n=10 Participants
MBL949 one 3 mg dose followed by two doses of 6 mg followed by five doses of 7.5 mg
|
Pooled MBL949
n=54 Participants
Pooled MBL949 arms
|
Placebo
n=31 Participants
Placebo to MBL949
|
MBL949 Arm 1
n=12 Participants
MBL949 one 3 mg dose followed by two doses of 6 mg followed by five doses of 4.5 mg
|
MBL949 Arm 2
n=8 Participants
MBL949 two 3 mg doses followed by six doses of 4.5 mg
|
MBL949 Arm 3
n=15 Participants
MBL949 one 12 mg dose followed by seven doses of 4.5 mg
|
MBL949 Arm 4
n=9 Participants
MBL949 one 1.5 mg dose followed by seven doses of 2.2 mg
|
|---|---|---|---|---|---|---|---|
|
Change-from-baseline in Weight
|
0.3 kg
Interval -0.9 to 1.5
|
-1.4 kg
Interval -2.0 to -0.8
|
-0.7 kg
Interval -1.4 to 0.0
|
-2.6 kg
Interval -3.8 to -1.5
|
-2.0 kg
Interval -3.3 to -0.8
|
-2.0 kg
Interval -3.0 to -0.9
|
-0.1 kg
Interval -1.4 to 1.1
|
Adverse Events
MBL949 Arm 1
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
MBL949 Arm 2
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
MBL949 Arm 3
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
MBL949 Arm 4
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
MBL949 Arm 5
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Pooled MBL949
Serious events: 0 serious events
Other events: 70 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Total
Serious events: 0 serious events
Other events: 96 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MBL949 Arm 1
n=14 participants at risk
MBL949 one 3 mg dose followed by two doses of 6 mg followed by five doses of 4.5 mg
|
MBL949 Arm 2
n=22 participants at risk
MBL949 two 3 mg doses followed by six doses of 4.5 mg
|
MBL949 Arm 3
n=16 participants at risk
MBL949 one 12 mg dose followed by seven doses of 4.5 mg
|
MBL949 Arm 4
n=15 participants at risk
MBL949 one 1.5 mg dose followed by seven doses of 2.2 mg
|
MBL949 Arm 5
n=15 participants at risk
MBL949 one 3 mg dose followed by two doses of 6 mg followed by five doses of 7.5 mg
|
Pooled MBL949
n=82 participants at risk
Pooled MBL949
|
Placebo
n=44 participants at risk
Placebo to MBL949
|
Total
n=126 participants at risk
Total
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Eye disorders
Vision blurred
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Eye disorders
Visual impairment
|
7.1%
1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Gastrointestinal disorders
Abdominal distension
|
14.3%
2/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
3.7%
3/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
11.4%
5/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.3%
8/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Gastrointestinal disorders
Abdominal pain
|
21.4%
3/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
13.3%
2/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.1%
5/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
2.3%
1/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
4.8%
6/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.1%
1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
3.7%
3/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
2.4%
3/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Gastrointestinal disorders
Constipation
|
21.4%
3/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
22.7%
5/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
31.2%
5/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
13.3%
2/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
19.5%
16/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
4.5%
2/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
14.3%
18/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Gastrointestinal disorders
Dental caries
|
7.1%
1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
9.1%
2/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
12.5%
2/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
13.3%
2/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
7.3%
6/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
11.4%
5/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
8.7%
11/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
2.4%
2/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
2.3%
1/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
2.4%
3/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
7.1%
1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.1%
1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
4.5%
1/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
3.7%
3/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
2.4%
3/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Gastrointestinal disorders
Nausea
|
64.3%
9/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
77.3%
17/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
87.5%
14/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
40.0%
6/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
80.0%
12/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
70.7%
58/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
38.6%
17/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
59.5%
75/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
45.5%
10/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
50.0%
8/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
40.0%
6/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
46.7%
7/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
39.0%
32/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.8%
3/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
27.8%
35/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
General disorders
Asthenia
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
General disorders
Chest discomfort
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
2.4%
2/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.6%
2/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
General disorders
Fatigue
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
22.7%
5/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
9.8%
8/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.3%
8/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
General disorders
Injection site pain
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
4.5%
2/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
2.4%
3/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
General disorders
Injection site reaction
|
7.1%
1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
3.7%
3/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
4.5%
2/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
4.0%
5/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
General disorders
Oedema peripheral
|
7.1%
1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
2.3%
1/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.6%
2/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Infections and infestations
Bronchitis
|
7.1%
1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Infections and infestations
COVID-19
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
4.5%
1/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
25.0%
4/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
7.3%
6/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
13.6%
6/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
9.5%
12/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
2.3%
1/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.6%
2/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Infections and infestations
Fungal foot infection
|
7.1%
1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Infections and infestations
Influenza
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
13.6%
3/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
12.5%
2/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
20.0%
3/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
11.0%
9/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
2.3%
1/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
7.9%
10/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Infections and infestations
Tinea cruris
|
7.1%
1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
4.5%
1/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
12.5%
2/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.1%
5/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.8%
3/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.3%
8/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
2.4%
2/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.6%
2/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Infections and infestations
Viral infection
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
13.6%
3/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
4.9%
4/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
3.2%
4/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Injury, poisoning and procedural complications
Muscle contusion
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
2.3%
1/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.6%
2/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Investigations
Cortisol free urine increased
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Investigations
Lipase increased
|
7.1%
1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Investigations
Pancreatic enzymes increased
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.1%
1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
18.8%
3/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.1%
5/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.8%
3/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.3%
8/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
7.1%
1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Metabolism and nutrition disorders
Food aversion
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
9.1%
2/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
2.4%
2/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.6%
2/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
4.5%
1/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
2.4%
2/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.6%
2/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.8%
3/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
3.2%
4/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
4.5%
1/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
2.4%
2/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.6%
2/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
7.1%
1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
2.3%
1/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.6%
2/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
2.4%
2/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.6%
2/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Nervous system disorders
Dysgeusia
|
7.1%
1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
3.7%
3/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
2.3%
1/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
3.2%
4/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Nervous system disorders
Headache
|
21.4%
3/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
18.2%
4/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
12.5%
2/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
13.3%
2/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
20.0%
3/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
17.1%
14/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
2.3%
1/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
11.9%
15/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
2.4%
2/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.6%
2/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Nervous system disorders
Syncope
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Nervous system disorders
Taste disorder
|
7.1%
1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
4.5%
1/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
2.4%
2/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.6%
2/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
4.5%
1/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
2.4%
2/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
2.3%
1/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
2.4%
3/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
2.3%
1/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.6%
2/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
1.2%
1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.79%
1/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
|
Vascular disorders
Hypertension
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
4.5%
1/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
12.5%
2/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
4.9%
4/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
0.00%
0/44 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
3.2%
4/126 • Adverse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 169 days.
Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER