Trial Outcomes & Findings for Combining Lesinurad With Allopurinol in Inadequate Responders (NCT NCT01510158)
NCT ID: NCT01510158
Last Updated: 2016-08-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
607 participants
Primary outcome timeframe
6 Months, analysis after all subjects complete 12 months
Results posted on
2016-08-18
Participant Flow
Participant milestones
| Measure |
Lesinurad 200 mg + Allopurinol
lesinurad 200 mg qd plus allopurinol
|
Lesinurad 400 mg + Allopurinol
lesinurad 400 mg qd plus allopurinol
|
Placebo + Allopurinol
placebo qd plus allopurinol
|
|---|---|---|---|
|
Overall Study
STARTED
|
202
|
203
|
202
|
|
Overall Study
COMPLETED
|
151
|
150
|
152
|
|
Overall Study
NOT COMPLETED
|
51
|
53
|
50
|
Reasons for withdrawal
| Measure |
Lesinurad 200 mg + Allopurinol
lesinurad 200 mg qd plus allopurinol
|
Lesinurad 400 mg + Allopurinol
lesinurad 400 mg qd plus allopurinol
|
Placebo + Allopurinol
placebo qd plus allopurinol
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
7
|
8
|
5
|
|
Overall Study
Gout flare
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
17
|
16
|
24
|
|
Overall Study
Sponsor terminated study.
|
2
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
13
|
16
|
9
|
|
Overall Study
Withdrawal by Subject
|
10
|
13
|
10
|
|
Overall Study
Death
|
1
|
0
|
0
|
Baseline Characteristics
Combining Lesinurad With Allopurinol in Inadequate Responders
Baseline characteristics by cohort
| Measure |
Lesinurad 200 mg + Allopurinol
n=201 Participants
lesinurad 200 mg qd plus allopurinol
|
Lesinurad 400 mg + Allopurinol
n=201 Participants
lesinurad 400 mg qd plus allopurinol
|
Placebo + Allopurinol
n=201 Participants
placebo qd plus allopurinol
|
Total
n=603 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.6 Years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
52.3 Years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
51.7 Years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
51.9 Years
STANDARD_DEVIATION 11.3 • n=4 Participants
|
|
Age, Customized
<65
|
181 Participants
n=5 Participants
|
168 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
518 Participants
n=4 Participants
|
|
Age, Customized
>=65
|
20 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
192 Participants
n=5 Participants
|
186 Participants
n=7 Participants
|
189 Participants
n=5 Participants
|
567 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
201 Participants
n=5 Participants
|
201 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
603 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 Months, analysis after all subjects complete 12 monthsPopulation: Intent-to-Treat Population
Outcome measures
| Measure |
Lesinurad 200 mg + Allopurinol
n=201 Participants
lesinurad 200 mg qd plus allopurinol
|
Lesinurad 400 mg + Allopurinol
n=201 Participants
lesinurad 400 mg qd plus allopurinol
|
Placebo + Allopurinol
n=201 Participants
placebo qd plus allopurinol
|
|---|---|---|---|
|
Proportion of Subjects With an sUA Level That is < 6.0 mg/dL
|
0.542 Proportion of Subjects
|
0.592 Proportion of Subjects
|
0.279 Proportion of Subjects
|
SECONDARY outcome
Timeframe: 12 MonthsMean rate of gout flares requiring treatment for the 6-month period from the end of Month 6 to the end of Month 12
Outcome measures
| Measure |
Lesinurad 200 mg + Allopurinol
n=201 Participants
lesinurad 200 mg qd plus allopurinol
|
Lesinurad 400 mg + Allopurinol
n=201 Participants
lesinurad 400 mg qd plus allopurinol
|
Placebo + Allopurinol
n=201 Participants
placebo qd plus allopurinol
|
|---|---|---|---|
|
Gout Flares
|
.60 Gout Flares
Standard Deviation 1.2
|
.50 Gout Flares
Standard Deviation 1.2
|
.60 Gout Flares
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 12 MonthsProportion of subjects with ≥ 1 target tophus at Baseline who experience complete resolution of at least 1 target tophus by Month 12
Outcome measures
| Measure |
Lesinurad 200 mg + Allopurinol
n=18 Participants
lesinurad 200 mg qd plus allopurinol
|
Lesinurad 400 mg + Allopurinol
n=19 Participants
lesinurad 400 mg qd plus allopurinol
|
Placebo + Allopurinol
n=17 Participants
placebo qd plus allopurinol
|
|---|---|---|---|
|
Tophus
|
0 Proportion of Subjects
|
0.211 Proportion of Subjects
|
0.294 Proportion of Subjects
|
Adverse Events
Lesinurad 200 mg + Allopurinol
Serious events: 9 serious events
Other events: 147 other events
Deaths: 0 deaths
Lesinurad 400 mg + Allopurinol
Serious events: 16 serious events
Other events: 156 other events
Deaths: 0 deaths
Placebo + Allopurinol
Serious events: 11 serious events
Other events: 138 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lesinurad 200 mg + Allopurinol
n=201 participants at risk
lesinurad 200 mg qd plus allopurinol
|
Lesinurad 400 mg + Allopurinol
n=201 participants at risk
lesinurad 400 mg qd plus allopurinol
|
Placebo + Allopurinol
n=201 participants at risk
placebo qd plus allopurinol
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Cardiac disorders
Angina pectoris
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Cardiac disorders
Cardiac arrest
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Cardiac disorders
Coronary artery disease
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
General disorders
Non-cardiac chest pain
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Influenza
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Vulval abscess
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Vulval cellulitis
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
|
Nervous system disorders
Vascular dementia
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Nervous system disorders
Vocal cord paralysis
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Renal and urinary disorders
Stag horn calculus
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
Other adverse events
| Measure |
Lesinurad 200 mg + Allopurinol
n=201 participants at risk
lesinurad 200 mg qd plus allopurinol
|
Lesinurad 400 mg + Allopurinol
n=201 participants at risk
lesinurad 400 mg qd plus allopurinol
|
Placebo + Allopurinol
n=201 participants at risk
placebo qd plus allopurinol
|
|---|---|---|---|
|
Cardiac disorders
Myocardial ischaemia
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Ear and labyrinth disorders
Deafness transitory
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Ear and labyrinth disorders
Inner ear inflammation
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Ear and labyrinth disorders
Vertigo
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Endocrine disorders
Androgen deficiency
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Cardiac disorders
Angina pectoris
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Cardiac disorders
Arrhythmia
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Endocrine disorders
Hypogonadism
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Endocrine disorders
Hypothyroidism
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Endocrine disorders
Thyroid disorder
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Eye disorders
Astigmatism
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Eye disorders
Blepharitis
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Eye disorders
Cataract
|
0.50%
1/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Eye disorders
Conjunctivitis
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Eye disorders
Eye pain
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Eye disorders
Glaucoma
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Eye disorders
Iridocyclitis
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Eye disorders
Iritis
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Eye disorders
Myopia
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Eye disorders
Ocular hyperaemia
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Eye disorders
Ocular icterus
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Eye disorders
Posterior capsule opacification
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Eye disorders
Presbyopia
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Eye disorders
Retinal tear
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Eye disorders
Vision blurred
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Eye disorders
Visual impairment
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.00%
2/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
2.0%
4/201 • Number of events 4
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Constipation
|
2.0%
4/201 • Number of events 4
Overall number of baseline participants used to determine number of participants at risk.
|
3.0%
6/201 • Number of events 6
Overall number of baseline participants used to determine number of participants at risk.
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Dental caries
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
8/201 • Number of events 8
Overall number of baseline participants used to determine number of participants at risk.
|
4.0%
8/201 • Number of events 8
Overall number of baseline participants used to determine number of participants at risk.
|
4.0%
8/201 • Number of events 8
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Dry mouth
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Eructation
|
0.50%
1/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Flatulence
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Food poisoning
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Gastritis
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Infrequent bowel movements
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Loose tooth
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Nausea
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
4.5%
9/201 • Number of events 11
Overall number of baseline participants used to determine number of participants at risk.
|
4.5%
9/201 • Number of events 9
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Proctalgia
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Toothache
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
6/201 • Number of events 6
Overall number of baseline participants used to determine number of participants at risk.
|
3.0%
6/201 • Number of events 6
Overall number of baseline participants used to determine number of participants at risk.
|
2.5%
5/201 • Number of events 5
Overall number of baseline participants used to determine number of participants at risk.
|
|
General disorders
Chest discomfort
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
General disorders
Chest pain
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
General disorders
Chills
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
2.5%
5/201 • Number of events 5
Overall number of baseline participants used to determine number of participants at risk.
|
|
General disorders
Cyst
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
General disorders
Device breakage
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
General disorders
Facial pain
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
General disorders
Fatigue
|
2.5%
5/201 • Number of events 5
Overall number of baseline participants used to determine number of participants at risk.
|
2.5%
5/201 • Number of events 5
Overall number of baseline participants used to determine number of participants at risk.
|
1.5%
3/201 • Number of events 4
Overall number of baseline participants used to determine number of participants at risk.
|
|
General disorders
Gait disturbance
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
General disorders
Influenza like illness
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
|
General disorders
Irritability
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
General disorders
Local swelling
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
|
General disorders
Non-cardiac chest pain
|
2.5%
5/201 • Number of events 7
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
|
General disorders
Oedema
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
General disorders
Oedema peripheral
|
2.0%
4/201 • Number of events 4
Overall number of baseline participants used to determine number of participants at risk.
|
3.0%
6/201 • Number of events 6
Overall number of baseline participants used to determine number of participants at risk.
|
2.5%
5/201 • Number of events 6
Overall number of baseline participants used to determine number of participants at risk.
|
|
General disorders
Pain
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
|
General disorders
Pyrexia
|
2.5%
5/201 • Number of events 6
Overall number of baseline participants used to determine number of participants at risk.
|
3.0%
6/201 • Number of events 6
Overall number of baseline participants used to determine number of participants at risk.
|
3.0%
6/201 • Number of events 6
Overall number of baseline participants used to determine number of participants at risk.
|
|
General disorders
Secretion discharge
|
0.50%
1/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
General disorders
Thirst
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
General disorders
Xerosis
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
2.0%
4/201 • Number of events 4
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Acute sinusitis
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Beta haemolytic streptococcal infection
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Bronchitis
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
3.5%
7/201 • Number of events 8
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Cellulitis
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Conjunctivitis infective
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Cystitis
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Ear infection
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Eye infection
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Folliculitis
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Fungal infection
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Furuncle
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Gastroenteritis
|
1.5%
3/201 • Number of events 4
Overall number of baseline participants used to determine number of participants at risk.
|
2.5%
5/201 • Number of events 5
Overall number of baseline participants used to determine number of participants at risk.
|
2.5%
5/201 • Number of events 5
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Gastroenteritis viral
|
2.0%
4/201 • Number of events 5
Overall number of baseline participants used to determine number of participants at risk.
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
2.0%
4/201 • Number of events 4
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Haemophilus infection
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Helicobacter infection
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Herpes zoster
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Hordeolum
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Influenza
|
2.5%
5/201 • Number of events 6
Overall number of baseline participants used to determine number of participants at risk.
|
3.0%
6/201 • Number of events 6
Overall number of baseline participants used to determine number of participants at risk.
|
4.0%
8/201 • Number of events 10
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Localised infection
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
1.5%
3/201 • Number of events 4
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Nail infection
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Nasopharyngitis
|
8.5%
17/201 • Number of events 23
Overall number of baseline participants used to determine number of participants at risk.
|
7.5%
15/201 • Number of events 18
Overall number of baseline participants used to determine number of participants at risk.
|
7.0%
14/201 • Number of events 17
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Oral herpes
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Otitis externa
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Paronychia
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Peptostreptococcus infection
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Pharyngitis
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Pharyngitis streptococcal
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Sinusitis
|
4.5%
9/201 • Number of events 11
Overall number of baseline participants used to determine number of participants at risk.
|
6.0%
12/201 • Number of events 15
Overall number of baseline participants used to determine number of participants at risk.
|
2.0%
4/201 • Number of events 4
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Skin candida
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Skin infection
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Subcutaneous abscess
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Tooth abscess
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
2.0%
4/201 • Number of events 4
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.9%
22/201 • Number of events 28
Overall number of baseline participants used to determine number of participants at risk.
|
9.0%
18/201 • Number of events 22
Overall number of baseline participants used to determine number of participants at risk.
|
5.5%
11/201 • Number of events 13
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Urinary tract infection
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
5.0%
10/201 • Number of events 10
Overall number of baseline participants used to determine number of participants at risk.
|
2.0%
4/201 • Number of events 5
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Viral infection
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Vulval abscess
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Vulval cellulitis
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Infections and infestations
Wound infection
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
2.0%
4/201 • Number of events 4
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Bite
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.0%
6/201 • Number of events 6
Overall number of baseline participants used to determine number of participants at risk.
|
3.5%
7/201 • Number of events 10
Overall number of baseline participants used to determine number of participants at risk.
|
3.0%
6/201 • Number of events 6
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Excoriation
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Fall
|
3.0%
6/201 • Number of events 7
Overall number of baseline participants used to determine number of participants at risk.
|
3.0%
6/201 • Number of events 7
Overall number of baseline participants used to determine number of participants at risk.
|
4.0%
8/201 • Number of events 9
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
1.5%
3/201 • Number of events 4
Overall number of baseline participants used to determine number of participants at risk.
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Laceration
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
5.0%
10/201 • Number of events 10
Overall number of baseline participants used to determine number of participants at risk.
|
5.0%
10/201 • Number of events 12
Overall number of baseline participants used to determine number of participants at risk.
|
3.5%
7/201 • Number of events 9
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Nail avulsion
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
Alanine aminotransferase increased
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
Aspartate aminotransferase increased
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
Blood amylase increased
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
Blood bicarbonate decreased
|
1.5%
3/201 • Number of events 4
Overall number of baseline participants used to determine number of participants at risk.
|
2.5%
5/201 • Number of events 7
Overall number of baseline participants used to determine number of participants at risk.
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
Blood creatine phosphokinase increased
|
4.5%
9/201 • Number of events 10
Overall number of baseline participants used to determine number of participants at risk.
|
8.0%
16/201 • Number of events 16
Overall number of baseline participants used to determine number of participants at risk.
|
2.5%
5/201 • Number of events 5
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
Blood creatinine increased
|
3.5%
7/201 • Number of events 11
Overall number of baseline participants used to determine number of participants at risk.
|
7.0%
14/201 • Number of events 19
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
Blood glucose increased
|
2.0%
4/201 • Number of events 5
Overall number of baseline participants used to determine number of participants at risk.
|
2.0%
4/201 • Number of events 4
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
Blood pressure increased
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
Blood testosterone decreased
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
Blood triglycerides increased
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
3.0%
6/201 • Number of events 6
Overall number of baseline participants used to determine number of participants at risk.
|
2.0%
4/201 • Number of events 4
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
Blood urea increased
|
1.00%
2/201 • Number of events 4
Overall number of baseline participants used to determine number of participants at risk.
|
1.5%
3/201 • Number of events 4
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
Blood urine present
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
Body temperature decreased
|
0.50%
1/201 • Number of events 4
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
Body temperature increased
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
Cardiac murmur
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
Cardiac stress test abnormal
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
Electrocardiogram qt prolonged
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
Electrocardiogram t wave abnormal
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
Electrocardiogram abnormal
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
1.5%
3/201 • Number of events 6
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
Glucose urine present
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
Haematocrit increased
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
Haemoglobin increased
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
Platelet count increased
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
Red blood cell count increased
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
Urine output decreased
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
Vitamin b12 decreased
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
White blood cell count decreased
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
White blood cell count increased
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
2.5%
5/201 • Number of events 5
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
2.0%
4/201 • Number of events 4
Overall number of baseline participants used to determine number of participants at risk.
|
2.5%
5/201 • Number of events 5
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Metabolism and nutrition disorders
Vitamin b complex deficiency
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.0%
8/201 • Number of events 9
Overall number of baseline participants used to determine number of participants at risk.
|
8.0%
16/201 • Number of events 18
Overall number of baseline participants used to determine number of participants at risk.
|
9.5%
19/201 • Number of events 23
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
2.0%
4/201 • Number of events 5
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.0%
16/201 • Number of events 18
Overall number of baseline participants used to determine number of participants at risk.
|
4.5%
9/201 • Number of events 12
Overall number of baseline participants used to determine number of participants at risk.
|
9.5%
19/201 • Number of events 21
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
2.0%
4/201 • Number of events 4
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.5%
3/201 • Number of events 4
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Joint hyperextension
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Medial tibial stress syndrome
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.00%
2/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
2.0%
4/201 • Number of events 5
Overall number of baseline participants used to determine number of participants at risk.
|
2.0%
4/201 • Number of events 5
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
4.5%
9/201 • Number of events 10
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
4.0%
8/201 • Number of events 8
Overall number of baseline participants used to determine number of participants at risk.
|
2.0%
4/201 • Number of events 4
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Myalgia intercostal
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Nodal osteoarthritis
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.5%
7/201 • Number of events 8
Overall number of baseline participants used to determine number of participants at risk.
|
2.5%
5/201 • Number of events 5
Overall number of baseline participants used to determine number of participants at risk.
|
4.5%
9/201 • Number of events 11
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
2.5%
5/201 • Number of events 5
Overall number of baseline participants used to determine number of participants at risk.
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroma
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Nervous system disorders
Cataplexy
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Nervous system disorders
Convulsion
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Nervous system disorders
Disturbance in attention
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Nervous system disorders
Dizziness
|
2.0%
4/201 • Number of events 5
Overall number of baseline participants used to determine number of participants at risk.
|
4.5%
9/201 • Number of events 9
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
|
Nervous system disorders
Dysgeusia
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Nervous system disorders
Headache
|
3.5%
7/201 • Number of events 9
Overall number of baseline participants used to determine number of participants at risk.
|
6.0%
12/201 • Number of events 15
Overall number of baseline participants used to determine number of participants at risk.
|
2.5%
5/201 • Number of events 5
Overall number of baseline participants used to determine number of participants at risk.
|
|
Nervous system disorders
Hypoaesthesia
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
2.0%
4/201 • Number of events 4
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Nervous system disorders
Loss of consciousness
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Nervous system disorders
Migraine
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
|
Nervous system disorders
Neuralgia
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.50%
1/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Nervous system disorders
Paraesthesia
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Nervous system disorders
Presyncope
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Nervous system disorders
Radiculitis brachial
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Nervous system disorders
Restless legs syndrome
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Nervous system disorders
Sciatica
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
|
Nervous system disorders
Sinus headache
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Nervous system disorders
Syncope
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Nervous system disorders
Tension headache
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Nervous system disorders
Tremor
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Nervous system disorders
Viith nerve paralysis
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Nervous system disorders
Vascular dementia
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Psychiatric disorders
Anxiety
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Psychiatric disorders
Depression
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
1.5%
3/201 • Number of events 5
Overall number of baseline participants used to determine number of participants at risk.
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Psychiatric disorders
Insomnia
|
2.5%
5/201 • Number of events 5
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
2.0%
4/201 • Number of events 4
Overall number of baseline participants used to determine number of participants at risk.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Psychiatric disorders
Libido increased
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Psychiatric disorders
Sleep disorder
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Renal and urinary disorders
Bladder dysfunction
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Renal and urinary disorders
Haematuria
|
2.0%
4/201 • Number of events 4
Overall number of baseline participants used to determine number of participants at risk.
|
2.0%
4/201 • Number of events 4
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
2.0%
4/201 • Number of events 4
Overall number of baseline participants used to determine number of participants at risk.
|
2.0%
4/201 • Number of events 4
Overall number of baseline participants used to determine number of participants at risk.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Renal and urinary disorders
Pyuria
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Renal and urinary disorders
Renal failure
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
|
Renal and urinary disorders
Stag horn calculus
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Renal and urinary disorders
Urethral perforation
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Reproductive system and breast disorders
Acquired hydrocele
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Reproductive system and breast disorders
Breast swelling
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Reproductive system and breast disorders
Haematospermia
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Reproductive system and breast disorders
Sexual dysfunction
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Reproductive system and breast disorders
Varicocele
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.50%
1/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
4/201 • Number of events 4
Overall number of baseline participants used to determine number of participants at risk.
|
2.0%
4/201 • Number of events 4
Overall number of baseline participants used to determine number of participants at risk.
|
2.5%
5/201 • Number of events 6
Overall number of baseline participants used to determine number of participants at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
2.5%
5/201 • Number of events 5
Overall number of baseline participants used to determine number of participants at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
2.5%
5/201 • Number of events 5
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.50%
1/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
2.0%
4/201 • Number of events 4
Overall number of baseline participants used to determine number of participants at risk.
|
1.5%
3/201 • Number of events 3
Overall number of baseline participants used to determine number of participants at risk.
|
2.0%
4/201 • Number of events 5
Overall number of baseline participants used to determine number of participants at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Vasomotor rhinitis
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Skin and subcutaneous tissue disorders
Dandruff
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.5%
3/201 • Number of events 5
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.5%
7/201 • Number of events 8
Overall number of baseline participants used to determine number of participants at risk.
|
2.5%
5/201 • Number of events 5
Overall number of baseline participants used to determine number of participants at risk.
|
2.0%
4/201 • Number of events 5
Overall number of baseline participants used to determine number of participants at risk.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Vascular disorders
Haematoma
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
|
Vascular disorders
Hot flush
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Vascular disorders
Hyperaemia
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Vascular disorders
Hypertension
|
4.0%
8/201 • Number of events 8
Overall number of baseline participants used to determine number of participants at risk.
|
3.5%
7/201 • Number of events 7
Overall number of baseline participants used to determine number of participants at risk.
|
3.5%
7/201 • Number of events 7
Overall number of baseline participants used to determine number of participants at risk.
|
|
Vascular disorders
Hypotension
|
1.00%
2/201 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/201
Overall number of baseline participants used to determine number of participants at risk.
|
0.50%
1/201 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI shall submit a copy of the Publication to Sponsor for review at least 45 days prior to its proposed submission. Sponsor reserves the right to delay any such publication for an additional period of 60 days. Upon Sponsor's request, PI agrees to delete from the proposed publication any Confidential Information. PI agrees not to release any publication without the prior written permission of Sponsor.
- Publication restrictions are in place
Restriction type: OTHER