Trial Outcomes & Findings for NFX-179 Topical Gel Treatment for Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF) (NCT NCT05005845)
NCT ID: NCT05005845
Last Updated: 2026-02-17
Results Overview
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an event that occurred or worsened on or after the first dose of study drug. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
199 participants
Primary outcome timeframe
Baseline (Day 1) up to Day 211
Results posted on
2026-02-17
Participant Flow
Participant milestones
| Measure |
NFX-179 Topical Gel Vehicle
NFX-179 topical gel vehicle was applied once daily to the target cutaneous neurofibromas (cNFs) for 182 days.
|
NFX-179 Topical Gel 0.5%
NFX-179 topical gel 0.5% was applied once daily to the target cNFs for 182 days.
|
NFX-179 Topical Gel 1.5%
NFX-179 topical gel 1.5% was applied once daily to the target cNFs for 182 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
67
|
66
|
66
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
67
|
66
|
66
|
|
Overall Study
COMPLETED
|
57
|
49
|
40
|
|
Overall Study
NOT COMPLETED
|
10
|
17
|
26
|
Reasons for withdrawal
| Measure |
NFX-179 Topical Gel Vehicle
NFX-179 topical gel vehicle was applied once daily to the target cutaneous neurofibromas (cNFs) for 182 days.
|
NFX-179 Topical Gel 0.5%
NFX-179 topical gel 0.5% was applied once daily to the target cNFs for 182 days.
|
NFX-179 Topical Gel 1.5%
NFX-179 topical gel 1.5% was applied once daily to the target cNFs for 182 days.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
5
|
17
|
|
Overall Study
Withdrawal by Subject
|
5
|
8
|
3
|
|
Overall Study
Protocol Violation
|
1
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
0
|
|
Overall Study
Other Than Specified
|
2
|
0
|
4
|
Baseline Characteristics
NFX-179 Topical Gel Treatment for Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF)
Baseline characteristics by cohort
| Measure |
NFX-179 Topical Gel Vehicle
n=67 Participants
NFX-179 topical gel vehicle was applied once daily to the target cNFs for 182 days.
|
NFX-179 Topical Gel 0.5%
n=66 Participants
NFX-179 topical gel 0.5% was applied once daily to the target cNFs for 182 days.
|
NFX-179 Topical Gel 1.5%
n=66 Participants
NFX-179 topical gel 1.5% was applied once daily to the target cNFs for 182 days.
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.69 years
STANDARD_DEVIATION 12.80 • n=25 Participants
|
50.53 years
STANDARD_DEVIATION 13.07 • n=20 Participants
|
50.09 years
STANDARD_DEVIATION 11.33 • n=45 Participants
|
50.77 years
STANDARD_DEVIATION 12.38 • n=76 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=25 Participants
|
47 Participants
n=20 Participants
|
47 Participants
n=45 Participants
|
134 Participants
n=76 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=25 Participants
|
19 Participants
n=20 Participants
|
19 Participants
n=45 Participants
|
65 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=25 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=45 Participants
|
7 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=25 Participants
|
52 Participants
n=20 Participants
|
52 Participants
n=45 Participants
|
157 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=25 Participants
|
12 Participants
n=20 Participants
|
11 Participants
n=45 Participants
|
35 Participants
n=76 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=25 Participants
|
3 Participants
n=20 Participants
|
2 Participants
n=45 Participants
|
10 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=25 Participants
|
7 Participants
n=20 Participants
|
7 Participants
n=45 Participants
|
20 Participants
n=76 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=25 Participants
|
54 Participants
n=20 Participants
|
55 Participants
n=45 Participants
|
164 Participants
n=76 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=25 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=45 Participants
|
5 Participants
n=76 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) up to Day 211Population: Safety Population included all randomized participants who received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety evaluation.
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an event that occurred or worsened on or after the first dose of study drug. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Outcome measures
| Measure |
NFX-179 Topical Gel 1.5%
n=66 Participants
NFX-179 topical gel 1.5% was applied once daily to the target cNFs for 182 days.
|
NFX-179 Topical Gel Vehicle
n=67 Participants
NFX-179 topical gel vehicle was applied once daily to the target cNFs for 182 days.
|
NFX-179 Topical Gel 0.5%
n=66 Participants
NFX-179 topical gel 0.5% was applied once daily to the target cNFs for 182 days.
|
|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
49 Participants
|
35 Participants
|
36 Participants
|
PRIMARY outcome
Timeframe: Day 182Population: The observed cases (OC) population included all participants who were randomized and dispensed study medication and had at least 1 post-baseline visit observed efficacy data at Day 182.
Treatment effectiveness was measured by the percentage of treated participants with at least 50% of target lesions with 50% reduction in cNF volume after 6 months of treatment. Tumor dimensions were measured using a standardized ruler.
Outcome measures
| Measure |
NFX-179 Topical Gel 1.5%
n=43 Participants
NFX-179 topical gel 1.5% was applied once daily to the target cNFs for 182 days.
|
NFX-179 Topical Gel Vehicle
n=58 Participants
NFX-179 topical gel vehicle was applied once daily to the target cNFs for 182 days.
|
NFX-179 Topical Gel 0.5%
n=52 Participants
NFX-179 topical gel 0.5% was applied once daily to the target cNFs for 182 days.
|
|---|---|---|---|
|
Percentage of Participants With At Least 50% of Target Lesions With 50% Reduction in cNF Volume Above the Surrounding Non-tumor Skin
|
44.2 percentage of participants
|
24.1 percentage of participants
|
34.6 percentage of participants
|
SECONDARY outcome
Timeframe: Day 182Population: The OC population included all participants who were randomized and dispensed study medication and had at least 1 post-baseline visit observed efficacy data at Day 182.
Treatment effectiveness was measured by the percentage of treated participants with at least 50% of target lesions with 50% reduction in cNF height after 6 months of treatment. Tumor dimensions were measured using a standardized ruler.
Outcome measures
| Measure |
NFX-179 Topical Gel 1.5%
n=43 Participants
NFX-179 topical gel 1.5% was applied once daily to the target cNFs for 182 days.
|
NFX-179 Topical Gel Vehicle
n=58 Participants
NFX-179 topical gel vehicle was applied once daily to the target cNFs for 182 days.
|
NFX-179 Topical Gel 0.5%
n=52 Participants
NFX-179 topical gel 0.5% was applied once daily to the target cNFs for 182 days.
|
|---|---|---|---|
|
Percentage of Participants With At Least 50% of Target Lesions With 50% Reduction in cNF Height Above the Surrounding Non-tumor Skin
|
39.5 percentage of participants
|
10.3 percentage of participants
|
23.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Day 182Population: The OC population included all participants who were randomized and dispensed study medication and had at least 1 post-baseline visit observed efficacy data at Day 182. Data are reported at participant-level, not tumor-level.
Mean percent change of tumor volume was calculated from ruler measurements throughout the course of treatment. Presented here are data analyzed at the participant level.
Outcome measures
| Measure |
NFX-179 Topical Gel 1.5%
n=43 Participants
NFX-179 topical gel 1.5% was applied once daily to the target cNFs for 182 days.
|
NFX-179 Topical Gel Vehicle
n=58 Participants
NFX-179 topical gel vehicle was applied once daily to the target cNFs for 182 days.
|
NFX-179 Topical Gel 0.5%
n=52 Participants
NFX-179 topical gel 0.5% was applied once daily to the target cNFs for 182 days.
|
|---|---|---|---|
|
Mean Percent Change From Baseline in cNF Volume at Day 182 Based on cNF Volume Derived From Ruler Measurements
|
-28.6 percent change
Standard Deviation 31.05
|
-14.7 percent change
Standard Deviation 40.28
|
-26.7 percent change
Standard Deviation 31.21
|
SECONDARY outcome
Timeframe: Baseline, Day 182Population: The OC population included all participants who were randomized and dispensed study medication and had at least 1 post-baseline visit observed efficacy data at Day 182. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. Data are reported at participant-level, not tumor-level.
Effect of treatment with the PTA was the investigator's assessment of the average overall severity of each Target cNF tumor at a particular time point. The PTA is a 5-point measuring tumor severity (0 = clear/none, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe). Presented here are data analyzed at the participant level.
Outcome measures
| Measure |
NFX-179 Topical Gel 1.5%
n=43 Participants
NFX-179 topical gel 1.5% was applied once daily to the target cNFs for 182 days.
|
NFX-179 Topical Gel Vehicle
n=57 Participants
NFX-179 topical gel vehicle was applied once daily to the target cNFs for 182 days.
|
NFX-179 Topical Gel 0.5%
n=52 Participants
NFX-179 topical gel 0.5% was applied once daily to the target cNFs for 182 days.
|
|---|---|---|---|
|
Change From Baseline in Tumor Severity Score Per Physician's Tumor Assessment (PTA) at Day 182
|
-0.4953 units on a scale
Standard Deviation 0.5089
|
-0.2439 units on a scale
Standard Deviation 0.5075
|
-0.3885 units on a scale
Standard Deviation 0.5105
|
SECONDARY outcome
Timeframe: Baseline, Day 182Population: The OC population included all participants who were randomized and dispensed study medication and had at least 1 post-baseline visit observed efficacy data at Day 182. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. Data are reported at participant-level, not tumor-level.
The SSA was the participant's assessment of the average overall severity of each Target cNF at a particular time point. The SSA is a 5-point measuring tumor severity (0 = clear/none, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe).
Outcome measures
| Measure |
NFX-179 Topical Gel 1.5%
n=43 Participants
NFX-179 topical gel 1.5% was applied once daily to the target cNFs for 182 days.
|
NFX-179 Topical Gel Vehicle
n=57 Participants
NFX-179 topical gel vehicle was applied once daily to the target cNFs for 182 days.
|
NFX-179 Topical Gel 0.5%
n=52 Participants
NFX-179 topical gel 0.5% was applied once daily to the target cNFs for 182 days.
|
|---|---|---|---|
|
Change From Baseline in Tumor Severity Score Per Subject's Self-Assessment (SSA) at Day 182
|
-0.6326 units on a scale
Standard Deviation 0.7539
|
-0.5000 units on a scale
Standard Deviation 0.8198
|
-0.8212 units on a scale
Standard Deviation 0.9757
|
Adverse Events
NFX-179 Topical Gel Vehicle
Serious events: 3 serious events
Other events: 35 other events
Deaths: 0 deaths
NFX-179 Topical Gel 0.5%
Serious events: 4 serious events
Other events: 36 other events
Deaths: 1 deaths
NFX-179 Topical Gel 1.5%
Serious events: 3 serious events
Other events: 49 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
NFX-179 Topical Gel Vehicle
n=67 participants at risk
NFX-179 topical gel vehicle was applied once daily to the target cNFs for 182 days.
|
NFX-179 Topical Gel 0.5%
n=66 participants at risk
NFX-179 topical gel 0.5% was applied once daily to the target cNFs for 182 days.
|
NFX-179 Topical Gel 1.5%
n=66 participants at risk
NFX-179 topical gel 1.5% was applied once daily to the target cNFs for 182 days.
|
|---|---|---|---|
|
Infections and infestations
Influenza
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Vascular disorders
Haematoma
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Infections and infestations
Cystitis
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Nervous system disorders
Central nervous system lesion
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Psychiatric disorders
Major depression
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
Other adverse events
| Measure |
NFX-179 Topical Gel Vehicle
n=67 participants at risk
NFX-179 topical gel vehicle was applied once daily to the target cNFs for 182 days.
|
NFX-179 Topical Gel 0.5%
n=66 participants at risk
NFX-179 topical gel 0.5% was applied once daily to the target cNFs for 182 days.
|
NFX-179 Topical Gel 1.5%
n=66 participants at risk
NFX-179 topical gel 1.5% was applied once daily to the target cNFs for 182 days.
|
|---|---|---|---|
|
Congenital, familial and genetic disorders
Meningocele
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Cardiac disorders
Chest pain
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Congenital, familial and genetic disorders
Neurofibromatosis
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Eye disorders
Eye haemorrhage
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
3.0%
2/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
3.0%
2/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Gastrointestinal disorders
Barrett"s oesophagus
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
3.0%
2/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
3.0%
2/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Gastrointestinal disorders
Pancreatic failure
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Gastrointestinal disorders
Umbilical hernia
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
General disorders
Chest discomfort
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
General disorders
Fatigue
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
General disorders
Gait disturbance
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
General disorders
Oedema
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
General disorders
Oedema peripheral
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
General disorders
Pain
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
3.0%
2/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
General disorders
Peripheral swelling
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
General disorders
Procedural pain
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
3.0%
2/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
General disorders
Pyrexia
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
General disorders
Vaccination site pain
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Hepatobiliary disorders
Hepatitis alcoholic
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Infections and infestations
Body tinea
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Infections and infestations
Bronchitis
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Infections and infestations
COVID-19
|
7.5%
5/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
6.1%
4/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
7.6%
5/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Infections and infestations
Conjunctivitis
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Infections and infestations
Cystitis
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
3.0%
2/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Infections and infestations
Lip infection
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Infections and infestations
Nasopharyngitis
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
6.1%
4/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
6.1%
4/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Infections and infestations
Otitis externa
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Infections and infestations
Otitis media
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Infections and infestations
Respiratory tract infection
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Infections and infestations
Scrotal cellulitis
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Infections and infestations
Sepsis
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Infections and infestations
Sinusitis bacterial
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
3.0%
2/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Infections and infestations
Urinary tract infection
|
3.0%
2/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
4.5%
3/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
3.0%
2/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Injury, poisoning and procedural complications
Accidental exposure to product
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
3.0%
2/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Injury, poisoning and procedural complications
Suture related complication
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Investigations
Alanine aminotransferase increased
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Investigations
Blood bilirubin increased
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Investigations
Blood potassium increased
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Investigations
Brain scan abnormal
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
3.0%
2/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
4.5%
3/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
3.0%
2/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast neoplasm
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neurofibroma
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Schwannoma
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Nervous system disorders
Headache
|
3.0%
2/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
3.0%
2/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Nervous system disorders
Migraine
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Nervous system disorders
Neurofibroma
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Nervous system disorders
Neuropathy peripheral
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Nervous system disorders
Sciatic nerve neuropathy
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Nervous system disorders
Seizure
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Nervous system disorders
Trigeminal neuralgia
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Nervous system disorders
Vertebral artery occlusion
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Psychiatric disorders
Depression
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Renal and urinary disorders
Bladder prolapse
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Reproductive system and breast disorders
Breast haematoma
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/27 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/19 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
5.3%
1/19 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.00%
0/27 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
5.3%
1/19 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/19 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
3.0%
2/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Application site discolouration
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
4.5%
3/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
3.0%
2/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
4.5%
3/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
15.2%
10/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Dermatitis psoriasiform
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
4.5%
3/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
15.2%
10/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
19.7%
13/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.0%
2/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
9.1%
6/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
22.7%
15/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
3.0%
2/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
3.0%
2/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Rash pustular
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
3.0%
2/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Skin abrasion
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
6.1%
4/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
6.1%
4/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
3.0%
2/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
4.5%
3/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Skin oedema
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
4.5%
3/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Surgical and medical procedures
Dental cosmetic procedure
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Surgical and medical procedures
Large intestinal polypectomy
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Surgical and medical procedures
Lipoma excision
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Surgical and medical procedures
Removal of foreign body
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Surgical and medical procedures
Skin lesion removal
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Surgical and medical procedures
Surgery
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Vascular disorders
Bloody discharge
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Vascular disorders
Haematoma
|
1.5%
1/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
|
Vascular disorders
Hypertension
|
0.00%
0/67 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
1.5%
1/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
0.00%
0/66 • Baseline (Day 1) up to Day 211
Safety Population included all randomized participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety evaluation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place