Trial Outcomes & Findings for A Phase 3 Study to Determine if RTB101 Prevents Clinically Symptomatic Respiratory Illness in the Elderly (NCT NCT04668352)
NCT ID: NCT04668352
Last Updated: 2021-06-23
Results Overview
To determine if RTB101 as compared to placebo decreases the percentage of subjects with clinically symptomatic respiratory illness (with or without an associated laboratory-confirmed pathogen) through Week 16
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1024 participants
Primary outcome timeframe
Week 0-16
Results posted on
2021-06-23
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo: Placebo
|
Dactolisib 10mg Once Daily
Dactolisib: TORC1 inhibitor
|
|---|---|---|
|
Overall Study
STARTED
|
511
|
513
|
|
Overall Study
COMPLETED
|
510
|
511
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 3 Study to Determine if RTB101 Prevents Clinically Symptomatic Respiratory Illness in the Elderly
Baseline characteristics by cohort
| Measure |
Placebo
n=510 Participants
Placebo: Placebo
|
Dactolisib 10mg Once Daily
n=511 Participants
Dactolisib: TORC1 inhibitor
|
Total
n=1021 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.1 Years
STANDARD_DEVIATION 5.83 • n=93 Participants
|
72.6 Years
STANDARD_DEVIATION 5.81 • n=4 Participants
|
72.8 Years
STANDARD_DEVIATION 5.82 • n=27 Participants
|
|
Age, Customized
>=65 and <85 years
|
486 Participants
n=93 Participants
|
488 Participants
n=4 Participants
|
974 Participants
n=27 Participants
|
|
Age, Customized
>=85 years
|
24 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
47 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
286 Participants
n=93 Participants
|
292 Participants
n=4 Participants
|
578 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
224 Participants
n=93 Participants
|
219 Participants
n=4 Participants
|
443 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
503 Participants
n=93 Participants
|
510 Participants
n=4 Participants
|
1013 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
8 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
498 Participants
n=93 Participants
|
490 Participants
n=4 Participants
|
988 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
New Zealand
|
510 participants
n=93 Participants
|
511 participants
n=4 Participants
|
1021 participants
n=27 Participants
|
|
Body Mass Index
|
28.8 kg/m^2
STANDARD_DEVIATION 5.13 • n=93 Participants
|
29.2 kg/m^2
STANDARD_DEVIATION 5.47 • n=4 Participants
|
29.0 kg/m^2
STANDARD_DEVIATION 5.31 • n=27 Participants
|
|
Received Current Season Influenza Vaccination
|
407 Participants
n=93 Participants
|
415 Participants
n=4 Participants
|
822 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Week 0-16To determine if RTB101 as compared to placebo decreases the percentage of subjects with clinically symptomatic respiratory illness (with or without an associated laboratory-confirmed pathogen) through Week 16
Outcome measures
| Measure |
Placebo
n=510 Participants
Placebo: Placebo
|
Dactolisib 10mg Once Daily
n=511 Participants
Dactolisib: TORC1 inhibitor
|
|---|---|---|
|
Percentage of Subjects With Clinically Symptomatic Respiratory Illness
|
125 Participants
|
134 Participants
|
Adverse Events
Placebo
Serious events: 32 serious events
Other events: 371 other events
Deaths: 0 deaths
Dactolisib 10mg Once Daily
Serious events: 31 serious events
Other events: 386 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo
n=510 participants at risk
Placebo: Placebo
|
Dactolisib 10mg Once Daily
n=511 participants at risk
Dactolisib: TORC1 inhibitor
|
|---|---|---|
|
Blood and lymphatic system disorders
Splenic embolism
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Cardiac disorders
Acute myocardial infarction
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Cardiac disorders
Atrial fibrillation
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Cardiac disorders
Coronary artery dissection
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Cardiac disorders
Coronary artery stenosis
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Cardiac disorders
Myocardial infarction
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Eye disorders
Cataract
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Eye disorders
Eye haemorrhage
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Gastrointestinal disorders
Nausea
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Gastrointestinal disorders
Pancreatitis
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Gastrointestinal disorders
Volvulus
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
General disorders
Fatigue
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
General disorders
Oedema peripheral
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Infections and infestations
Biliary sepsis
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Infections and infestations
Cellulitis
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Infections and infestations
Pneumonia
|
0.39%
2/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Infections and infestations
Sepsis
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Infections and infestations
Urosepsis
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Infections and infestations
Vestibular neuronitis
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Investigations
Metabolism and nutrition disorders
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Investigations
Hyponatraemia
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Loose body in joint
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.2%
6/510 • Up to Week 16
|
2.2%
11/511 • Up to Week 16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.39%
2/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Nervous system disorders
Cerebral infarction
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Nervous system disorders
Cerebrovascular accident
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Nervous system disorders
Dizziness
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Nervous system disorders
Migraine
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Nervous system disorders
Presyncope
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Nervous system disorders
Syncope
|
0.39%
2/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Renal and urinary disorders
Haematuria
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Renal and urinary disorders
Renal embolism
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Renal and urinary disorders
Urinary retention
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Surgical and medical procedures
Cancer surgery
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Vascular disorders
Hypertension
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
Other adverse events
| Measure |
Placebo
n=510 participants at risk
Placebo: Placebo
|
Dactolisib 10mg Once Daily
n=511 participants at risk
Dactolisib: TORC1 inhibitor
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
7/510 • Up to Week 16
|
1.4%
7/511 • Up to Week 16
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.39%
2/510 • Up to Week 16
|
0.59%
3/511 • Up to Week 16
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Blood and lymphatic system disorders
Splenic embolism
|
0.20%
1/510 • Up to Week 16
|
0.59%
3/511 • Up to Week 16
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Cardiac disorders
Acute myocardial infarction
|
3.7%
19/510 • Up to Week 16
|
3.1%
16/511 • Up to Week 16
|
|
Cardiac disorders
Angina pectoris
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Cardiac disorders
Atrial flutter
|
2.0%
10/510 • Up to Week 16
|
1.2%
6/511 • Up to Week 16
|
|
Cardiac disorders
Bradycardia
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Cardiac disorders
Coronary artery dissection
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Cardiac disorders
Coronary artery stenosis
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Cardiac disorders
Myocardial infarction
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Cardiac disorders
Palpitations
|
0.78%
4/510 • Up to Week 16
|
0.78%
4/511 • Up to Week 16
|
|
Cardiac disorders
Sinus tachycardia
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.39%
2/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/510 • Up to Week 16
|
0.59%
3/511 • Up to Week 16
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Ear and labyrinth disorders
Eustachian tube obstruction
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Ear and labyrinth disorders
Excessive cerumen production
|
0.00%
0/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Ear and labyrinth disorders
Motion sickness
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Ear and labyrinth disorders
Tinnitus
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Ear and labyrinth disorders
Vertigo
|
0.78%
4/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.20%
1/510 • Up to Week 16
|
0.59%
3/511 • Up to Week 16
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Eye disorders
Amaurosis fugax
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Eye disorders
Blepharitis
|
0.39%
2/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Eye disorders
Cataract
|
0.20%
1/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Eye disorders
Conjunctival haemorrhage
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Eye disorders
Dry eye
|
0.00%
0/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Eye disorders
Episcleritis
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Eye disorders
Eye discharge
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Eye disorders
Eye haemorrhage
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Eye disorders
Eye pain
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Eye disorders
Eye pruritus
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Eye disorders
Eyelid haematoma
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Eye disorders
Glaucoma
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Eye disorders
Keratoconus
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Eye disorders
Lacrimation increased
|
0.39%
2/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Eye disorders
Macular degeneration
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Eye disorders
Myopia
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Eye disorders
Photophobia
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Eye disorders
Retinal haemorrhage
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Eye disorders
Scleritis
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Eye disorders
Visual impairment
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Eye disorders
Vitreous floaters
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Gastrointestinal disorders
Anal incontinence
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Gastrointestinal disorders
Anal pruritus
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/510 • Up to Week 16
|
0.59%
3/511 • Up to Week 16
|
|
Gastrointestinal disorders
Change of bowel habit
|
0.39%
2/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Gastrointestinal disorders
Colitis
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Gastrointestinal disorders
Constipation
|
1.2%
6/510 • Up to Week 16
|
1.2%
6/511 • Up to Week 16
|
|
Gastrointestinal disorders
Dental caries
|
0.39%
2/510 • Up to Week 16
|
0.59%
3/511 • Up to Week 16
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
34/510 • Up to Week 16
|
6.8%
35/511 • Up to Week 16
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Gastrointestinal disorders
Discoloured vomit
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Gastrointestinal disorders
Diverticulum
|
0.39%
2/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Gastrointestinal disorders
Dry mouth
|
0.39%
2/510 • Up to Week 16
|
0.98%
5/511 • Up to Week 16
|
|
Gastrointestinal disorders
Dyspepsia
|
0.20%
1/510 • Up to Week 16
|
0.98%
5/511 • Up to Week 16
|
|
Gastrointestinal disorders
Dysphagia
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Gastrointestinal disorders
Eructation
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.39%
2/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Gastrointestinal disorders
Faeces hard
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Gastrointestinal disorders
Flatulence
|
0.59%
3/510 • Up to Week 16
|
0.59%
3/511 • Up to Week 16
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Gastrointestinal disorders
Gastritis
|
0.20%
1/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.4%
7/510 • Up to Week 16
|
0.98%
5/511 • Up to Week 16
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Gastrointestinal disorders
Haematochezia
|
0.39%
2/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.39%
2/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Gastrointestinal disorders
Lip blister
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Gastrointestinal disorders
Lip pain
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Gastrointestinal disorders
Lip ulceration
|
0.39%
2/510 • Up to Week 16
|
1.2%
6/511 • Up to Week 16
|
|
Gastrointestinal disorders
Mouth ulceration
|
1.2%
6/510 • Up to Week 16
|
1.8%
9/511 • Up to Week 16
|
|
Gastrointestinal disorders
Nausea
|
2.2%
11/510 • Up to Week 16
|
1.4%
7/511 • Up to Week 16
|
|
Gastrointestinal disorders
Oral discomfort
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Gastrointestinal disorders
Pancreatitis
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.39%
2/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Gastrointestinal disorders
Stomatitis
|
0.39%
2/510 • Up to Week 16
|
0.59%
3/511 • Up to Week 16
|
|
Gastrointestinal disorders
Tongue disorder
|
0.39%
2/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Gastrointestinal disorders
Tongue erythema
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Gastrointestinal disorders
Tooth loss
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Gastrointestinal disorders
Toothache
|
0.20%
1/510 • Up to Week 16
|
0.98%
5/511 • Up to Week 16
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Gastrointestinal disorders
Uvulitis
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Gastrointestinal disorders
Volvulus
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
9/510 • Up to Week 16
|
0.78%
4/511 • Up to Week 16
|
|
General disorders
Adverse drug reaction
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
General disorders
Application site erosion
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
General disorders
Application site rash
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
General disorders
Asthenia
|
1.4%
7/510 • Up to Week 16
|
1.8%
9/511 • Up to Week 16
|
|
General disorders
Chest discomfort
|
0.59%
3/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
General disorders
Chest pain
|
1.2%
6/510 • Up to Week 16
|
0.98%
5/511 • Up to Week 16
|
|
General disorders
Chills
|
0.20%
1/510 • Up to Week 16
|
0.78%
4/511 • Up to Week 16
|
|
General disorders
Drug intolerance
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
General disorders
Facial pain
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
General disorders
Fatigue
|
2.2%
11/510 • Up to Week 16
|
2.3%
12/511 • Up to Week 16
|
|
General disorders
Influenza like illness
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
General disorders
Malaise
|
0.39%
2/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
General disorders
Medical device pain
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
General disorders
Oedema peripheral
|
0.59%
3/510 • Up to Week 16
|
0.78%
4/511 • Up to Week 16
|
|
General disorders
Pain
|
1.6%
8/510 • Up to Week 16
|
0.98%
5/511 • Up to Week 16
|
|
General disorders
Peripheral swelling
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
General disorders
Pyrexia
|
0.59%
3/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
General disorders
Therapeutic response unexpected
|
11.6%
59/510 • Up to Week 16
|
12.9%
66/511 • Up to Week 16
|
|
General disorders
Vessel puncture site bruise
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Immune system disorders
Allergy to plants
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Immune system disorders
Seasonal allergy
|
1.8%
9/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Infections and infestations
Abscess limb
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Infections and infestations
Anal candidiasis
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Infections and infestations
Bacteriuria
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Infections and infestations
Biliary sepsis
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Infections and infestations
Bronchitis
|
0.20%
1/510 • Up to Week 16
|
0.98%
5/511 • Up to Week 16
|
|
Infections and infestations
Bursitis infective
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Infections and infestations
Candida infection
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Infections and infestations
Cellulitis
|
0.39%
2/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Infections and infestations
Conjunctivitis
|
0.20%
1/510 • Up to Week 16
|
0.98%
5/511 • Up to Week 16
|
|
Infections and infestations
Corona virus infection
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Infections and infestations
Cystitis
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Infections and infestations
Diverticulitis
|
0.39%
2/510 • Up to Week 16
|
0.78%
4/511 • Up to Week 16
|
|
Infections and infestations
Ear infection
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Infections and infestations
Folliculitis
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Infections and infestations
Fungal skin infection
|
0.39%
2/510 • Up to Week 16
|
0.59%
3/511 • Up to Week 16
|
|
Infections and infestations
Furuncle
|
0.39%
2/510 • Up to Week 16
|
0.59%
3/511 • Up to Week 16
|
|
Infections and infestations
Gastroenteritis
|
1.8%
9/510 • Up to Week 16
|
1.8%
9/511 • Up to Week 16
|
|
Infections and infestations
Gastroenteritis viral
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Infections and infestations
Genital herpes
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Infections and infestations
Gingivitis
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Infections and infestations
Herpes zoster
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Infections and infestations
Hordeolum
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Infections and infestations
Infected bite
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Infections and infestations
Infected dermal cyst
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Infections and infestations
Laryngitis
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Infections and infestations
Lice infestation
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Infections and infestations
Lip infection
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Infections and infestations
Localised infection
|
0.78%
4/510 • Up to Week 16
|
0.59%
3/511 • Up to Week 16
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Infections and infestations
Medical device site infection
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Infections and infestations
Nail infection
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Infections and infestations
Nasal herpes
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Infections and infestations
Oral candidiasis
|
0.20%
1/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Infections and infestations
Oral herpes
|
3.1%
16/510 • Up to Week 16
|
1.4%
7/511 • Up to Week 16
|
|
Infections and infestations
Otitis externa
|
0.78%
4/510 • Up to Week 16
|
0.78%
4/511 • Up to Week 16
|
|
Infections and infestations
Otitis media
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Infections and infestations
Paronychia
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Infections and infestations
Periodontitis
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Infections and infestations
Pertussis
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Infections and infestations
Pneumonia
|
0.39%
2/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Infections and infestations
Postoperative wound infection
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Infections and infestations
Rhinitis
|
0.98%
5/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Infections and infestations
Root canal infection
|
0.39%
2/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Infections and infestations
Sepsis
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Infections and infestations
Sinusitis
|
0.39%
2/510 • Up to Week 16
|
1.2%
6/511 • Up to Week 16
|
|
Infections and infestations
Skin infection
|
0.00%
0/510 • Up to Week 16
|
0.98%
5/511 • Up to Week 16
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Infections and infestations
Tooth abscess
|
0.78%
4/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Infections and infestations
Tooth infection
|
0.39%
2/510 • Up to Week 16
|
1.2%
6/511 • Up to Week 16
|
|
Infections and infestations
Upper respiratory tract infection
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Infections and infestations
Urinary tract infection
|
4.1%
21/510 • Up to Week 16
|
2.9%
15/511 • Up to Week 16
|
|
Infections and infestations
Urosepsis
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Infections and infestations
Vestibular neuronitis
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Infections and infestations
Viral infection
|
0.59%
3/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Infections and infestations
Viral rash
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Infections and infestations
Viral rhinitis
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.20%
1/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Infections and infestations
Wound infection
|
0.39%
2/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Anal injury
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.39%
2/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.00%
0/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.20%
1/510 • Up to Week 16
|
0.59%
3/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Back injury
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.39%
2/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Chillblains
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Contusion
|
2.0%
10/510 • Up to Week 16
|
4.3%
22/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Dental restoration failure
|
0.39%
2/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Extra dose administered
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Eyelid injury
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Fall
|
5.5%
28/510 • Up to Week 16
|
3.9%
20/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.59%
3/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.59%
3/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.4%
7/510 • Up to Week 16
|
2.0%
10/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.20%
1/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.20%
1/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Muscle strain
|
2.0%
10/510 • Up to Week 16
|
3.1%
16/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Musculoskeletal injury
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Nail avulsion
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Nail injury
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Palate injury
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Pharyngeal injury
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Post concussion syndrome
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Post procedural constipation
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.39%
2/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.98%
5/510 • Up to Week 16
|
0.59%
3/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Repetitive strain injury
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.39%
2/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Scratch
|
0.39%
2/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
2.7%
14/510 • Up to Week 16
|
4.1%
21/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Skin laceration
|
1.6%
8/510 • Up to Week 16
|
2.2%
11/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.39%
2/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.59%
3/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Injury, poisoning and procedural complications
Wound
|
0.39%
2/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Investigations
Alanine aminotransferase increased
|
0.39%
2/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Investigations
Biopsy skin
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Investigations
Blood alkaline phosphatase increased
|
0.20%
1/510 • Up to Week 16
|
0.59%
3/511 • Up to Week 16
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Investigations
Blood creatinine increased
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Investigations
Blood glucose decreased
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Investigations
Blood glucose increased
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Investigations
Blood potassium increased
|
0.00%
0/510 • Up to Week 16
|
0.98%
5/511 • Up to Week 16
|
|
Investigations
Blood pressure increased
|
0.39%
2/510 • Up to Week 16
|
0.59%
3/511 • Up to Week 16
|
|
Investigations
Cardiac murmur
|
0.59%
3/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Investigations
Electrocardiogram QT prolonged
|
0.59%
3/510 • Up to Week 16
|
1.4%
7/511 • Up to Week 16
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Investigations
Eosinophil count increased
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Investigations
Faecal volume increased
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Investigations
Fibrin D dimer increased
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Investigations
Glomerular filtration rate decreased
|
0.39%
2/510 • Up to Week 16
|
0.59%
3/511 • Up to Week 16
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Investigations
Haematocrit increased
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Investigations
Haemoglobin decreased
|
0.20%
1/510 • Up to Week 16
|
0.98%
5/511 • Up to Week 16
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Investigations
Laboratory test abnormal
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Investigations
Liver function test abnormal
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Investigations
Liver function test increased
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Investigations
Neutrophil count decreased
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Investigations
Occult blood positive
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Investigations
Platelet count decreased
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Investigations
Platelet count increased
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Investigations
Prostatic specific antigen increased
|
0.39%
2/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Investigations
Red blood cells urine positive
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Investigations
Renal function test abnormal
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Investigations
Transaminases increased
|
0.00%
0/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Investigations
Urinary sediment present
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Investigations
Urine albumin/creatinine ratio increased
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Investigations
Vitamin B12 decreased
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Investigations
Vitamin D decreased
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Investigations
Weight decreased
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Investigations
Weight increased
|
0.39%
2/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Investigations
White blood cell count increased
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Investigations
White blood cells urine positive
|
0.39%
2/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.39%
2/510 • Up to Week 16
|
1.4%
7/511 • Up to Week 16
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Metabolism and nutrition disorders
Gout
|
0.39%
2/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/510 • Up to Week 16
|
0.59%
3/511 • Up to Week 16
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.39%
2/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.78%
4/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.59%
3/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.39%
2/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Metabolism and nutrition disorders
Salt craving
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.20%
1/510 • Up to Week 16
|
0.78%
4/511 • Up to Week 16
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.4%
12/510 • Up to Week 16
|
4.1%
21/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.39%
2/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
15/510 • Up to Week 16
|
2.2%
11/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.98%
5/510 • Up to Week 16
|
0.78%
4/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Inguinal mass
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.39%
2/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Limb mass
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Loose body in joint
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Metatarsalgia
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.98%
5/510 • Up to Week 16
|
1.8%
9/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.98%
5/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.78%
4/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.98%
5/510 • Up to Week 16
|
1.4%
7/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/510 • Up to Week 16
|
1.2%
6/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.59%
3/510 • Up to Week 16
|
0.78%
4/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.78%
4/510 • Up to Week 16
|
1.2%
6/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.6%
8/510 • Up to Week 16
|
2.5%
13/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/510 • Up to Week 16
|
0.59%
3/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.78%
4/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/510 • Up to Week 16
|
0.59%
3/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.2%
6/510 • Up to Week 16
|
2.2%
11/511 • Up to Week 16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibrous histiocytoma
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral neoplasm
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.78%
4/510 • Up to Week 16
|
0.78%
4/511 • Up to Week 16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.39%
2/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Nervous system disorders
Amnesia
|
0.39%
2/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Nervous system disorders
Aphonia
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Nervous system disorders
Balance disorder
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Nervous system disorders
Cerebral infarction
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Nervous system disorders
Cerebrovascular accident
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Nervous system disorders
Circadian rhythm sleep disorder
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Nervous system disorders
Dizziness
|
2.5%
13/510 • Up to Week 16
|
2.5%
13/511 • Up to Week 16
|
|
Nervous system disorders
Dizziness postural
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Nervous system disorders
Facial neuralgia
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Nervous system disorders
Headache
|
5.1%
26/510 • Up to Week 16
|
7.2%
37/511 • Up to Week 16
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Nervous system disorders
Hyposmia
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Nervous system disorders
Lethargy
|
1.2%
6/510 • Up to Week 16
|
1.8%
9/511 • Up to Week 16
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Nervous system disorders
Migraine
|
0.39%
2/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Nervous system disorders
Paraesthesia
|
0.78%
4/510 • Up to Week 16
|
0.59%
3/511 • Up to Week 16
|
|
Nervous system disorders
Presyncope
|
0.39%
2/510 • Up to Week 16
|
0.59%
3/511 • Up to Week 16
|
|
Nervous system disorders
Sciatica
|
0.39%
2/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Nervous system disorders
Sedation
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Nervous system disorders
Somnolence
|
0.20%
1/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Nervous system disorders
Syncope
|
0.98%
5/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Nervous system disorders
Tension headache
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Nervous system disorders
Tremor
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Nervous system disorders
Vascular parkinsonism
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Product Issues
Device breakage
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Psychiatric disorders
Anxiety
|
0.20%
1/510 • Up to Week 16
|
0.78%
4/511 • Up to Week 16
|
|
Psychiatric disorders
Apathy
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Psychiatric disorders
Delirium
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Psychiatric disorders
Depressed mood
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Psychiatric disorders
Depression
|
0.20%
1/510 • Up to Week 16
|
0.59%
3/511 • Up to Week 16
|
|
Psychiatric disorders
Insomnia
|
0.78%
4/510 • Up to Week 16
|
0.59%
3/511 • Up to Week 16
|
|
Renal and urinary disorders
Acute kidney injury
|
0.39%
2/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Renal and urinary disorders
Haematuria
|
0.59%
3/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Renal and urinary disorders
Hydronephrosis
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Renal and urinary disorders
Lower urinary tract symptoms
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Renal and urinary disorders
Pollakiuria
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Renal and urinary disorders
Renal embolism
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Renal and urinary disorders
Renal impairment
|
0.98%
5/510 • Up to Week 16
|
0.78%
4/511 • Up to Week 16
|
|
Renal and urinary disorders
Renal infarct
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Renal and urinary disorders
Urinary retention
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Renal and urinary disorders
Urinary tract discomfort
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Reproductive system and breast disorders
Atrophic vulvovaginitis
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.39%
2/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Reproductive system and breast disorders
Prostatitis
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.4%
12/510 • Up to Week 16
|
3.5%
18/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.78%
4/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.78%
4/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.59%
3/510 • Up to Week 16
|
1.4%
7/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.20%
1/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.4%
12/510 • Up to Week 16
|
1.8%
9/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal erosion
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal ulcer
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum ulceration
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Nasal ulcer
|
0.00%
0/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.59%
3/510 • Up to Week 16
|
0.59%
3/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal ulceration
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Pleural rub
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.59%
3/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis perennial
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.39%
2/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.39%
2/510 • Up to Week 16
|
0.59%
3/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.39%
2/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Yawning
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
1.6%
8/510 • Up to Week 16
|
1.6%
8/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/510 • Up to Week 16
|
0.59%
3/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.98%
5/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.39%
2/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.59%
3/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.98%
5/510 • Up to Week 16
|
1.2%
6/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.39%
2/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Lichen planus
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Lichen sclerosus
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Onychomalacia
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Pemphigus
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.59%
3/510 • Up to Week 16
|
1.2%
6/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.6%
8/510 • Up to Week 16
|
2.5%
13/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/510 • Up to Week 16
|
0.59%
3/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.39%
2/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
1.6%
8/510 • Up to Week 16
|
0.98%
5/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.20%
1/510 • Up to Week 16
|
0.59%
3/511 • Up to Week 16
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.39%
2/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Surgical and medical procedures
Cancer surgery
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Surgical and medical procedures
Cataract operation
|
0.20%
1/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Surgical and medical procedures
Eyelid operation
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Surgical and medical procedures
Gastric polypectomy
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Surgical and medical procedures
Hernia repair
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Surgical and medical procedures
Joint irrigation
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Surgical and medical procedures
Lipoma excision
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Surgical and medical procedures
Prostatectomy
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Surgical and medical procedures
Ptosis repair
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Surgical and medical procedures
Skin lesion removal
|
0.39%
2/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Surgical and medical procedures
Skin neoplasm excision
|
0.00%
0/510 • Up to Week 16
|
0.39%
2/511 • Up to Week 16
|
|
Surgical and medical procedures
Spinal decompression
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Surgical and medical procedures
Tooth extraction
|
0.39%
2/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Surgical and medical procedures
Urethral dilation procedure
|
0.20%
1/510 • Up to Week 16
|
0.00%
0/511 • Up to Week 16
|
|
Surgical and medical procedures
Vitrectomy
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Vascular disorders
Flushing
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Vascular disorders
Haematoma
|
0.59%
3/510 • Up to Week 16
|
0.98%
5/511 • Up to Week 16
|
|
Vascular disorders
Hot flush
|
0.20%
1/510 • Up to Week 16
|
0.59%
3/511 • Up to Week 16
|
|
Vascular disorders
Hypertension
|
1.8%
9/510 • Up to Week 16
|
3.7%
19/511 • Up to Week 16
|
|
Vascular disorders
Hypotension
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Vascular disorders
Orthostatic hypotension
|
0.20%
1/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
|
Vascular disorders
Phlebitis
|
0.00%
0/510 • Up to Week 16
|
0.20%
1/511 • Up to Week 16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place