Trial Outcomes & Findings for 12-Month Open-Label Extension Study of Intepirdine (RVT-101) in Subjects With Alzheimer's Disease: MINDSET Extension (NCT NCT02586909)
NCT ID: NCT02586909
Last Updated: 2020-04-17
Results Overview
The primary outcome measure is to study the safety of Intepridine (RVT-101) by determining the incidence of AEs, changes in physical examinations, vital signs measurements, ECGs and clinical laboratory assessments
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
1099 participants
Primary outcome timeframe
Baseline to 12 months or Early Termination
Results posted on
2020-04-17
Participant Flow
Participant milestones
| Measure |
RVT-101 35 mg Tablets
once daily, oral tablets
RVT-101 35 mg tablets: once daily, oral tablets
|
|---|---|
|
Overall Study
STARTED
|
1099
|
|
Overall Study
COMPLETED
|
151
|
|
Overall Study
NOT COMPLETED
|
948
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
12-Month Open-Label Extension Study of Intepirdine (RVT-101) in Subjects With Alzheimer's Disease: MINDSET Extension
Baseline characteristics by cohort
| Measure |
RVT-101 35 mg Tablets
n=1099 Participants
once daily, oral tablets
RVT-101 35 mg tablets: once daily, oral tablets
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
158 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
941 Participants
n=5 Participants
|
|
Age, Continuous
|
73.1 years
STANDARD_DEVIATION 7.55 • n=5 Participants
|
|
Sex: Female, Male
Female
|
676 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
423 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
193 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
897 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1022 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
103 participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
16 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
281 participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
53 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
164 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
65 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
37 participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
16 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
47 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
61 participants
n=5 Participants
|
|
Region of Enrollment
Slovakia
|
42 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
31 participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Chile
|
48 participants
n=5 Participants
|
|
Region of Enrollment
France
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Serbia
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
55 participants
n=5 Participants
|
|
Region of Enrollment
Croatia
|
30 participants
n=5 Participants
|
|
Height
|
163.3 cm
STANDARD_DEVIATION 9.86 • n=5 Participants
|
|
Weight
|
71.08 kg
STANDARD_DEVIATION 14.490 • n=5 Participants
|
|
Body Mass Index (BMI)
|
26.59 kg/m^2
STANDARD_DEVIATION 4.653 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 months or Early TerminationThe primary outcome measure is to study the safety of Intepridine (RVT-101) by determining the incidence of AEs, changes in physical examinations, vital signs measurements, ECGs and clinical laboratory assessments
Outcome measures
| Measure |
RVT-101 35 mg Tablets
n=1099 Participants
once daily, oral tablets
RVT-101 35 mg tablets: once daily, oral tablets
|
|---|---|
|
Occurrence of Adverse Events (AEs) and or Reported Changes in Physical Examinations, Vital Signs Measurements, Electrocardiograms (ECGs), Routine Laboratory Assessments
Subjects with at least one on-treatment AE
|
549 Participants
|
|
Occurrence of Adverse Events (AEs) and or Reported Changes in Physical Examinations, Vital Signs Measurements, Electrocardiograms (ECGs), Routine Laboratory Assessments
Subjects with no on-Treatment AE
|
550 Participants
|
Adverse Events
RVT-101 35 mg Tablets
Serious events: 87 serious events
Other events: 526 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
RVT-101 35 mg Tablets
n=1099 participants at risk
once daily, oral tablets
RVT-101 35 mg tablets: once daily, oral tablets
|
|---|---|
|
Infections and infestations
Pneumonia
|
0.36%
4/1099 • 1 Year
|
|
Infections and infestations
Gastroenteritis
|
0.27%
3/1099 • 1 Year
|
|
Infections and infestations
Appendicitis perforated
|
0.18%
2/1099 • 1 Year
|
|
Infections and infestations
Urinary tract infection
|
0.18%
2/1099 • 1 Year
|
|
Infections and infestations
Urosepsis
|
0.18%
2/1099 • 1 Year
|
|
Infections and infestations
Bronchitis
|
0.09%
1/1099 • 1 Year
|
|
Infections and infestations
Cellulitis
|
0.09%
1/1099 • 1 Year
|
|
Infections and infestations
Diverticulitis
|
0.09%
1/1099 • 1 Year
|
|
Infections and infestations
Infected skin ulcer
|
0.09%
1/1099 • 1 Year
|
|
Infections and infestations
Oesophageal candidiasis
|
0.09%
1/1099 • 1 Year
|
|
Infections and infestations
Pyelonephritis acute
|
0.09%
1/1099 • 1 Year
|
|
Infections and infestations
Sepsis
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Fall
|
0.45%
5/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Contusion
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Postoperative delirium
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.09%
1/1099 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.27%
3/1099 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.09%
1/1099 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.09%
1/1099 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.09%
1/1099 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.09%
1/1099 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.09%
1/1099 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.09%
1/1099 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage I
|
0.09%
1/1099 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.09%
1/1099 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.09%
1/1099 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mycosis fungoides
|
0.09%
1/1099 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.09%
1/1099 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.09%
1/1099 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.09%
1/1099 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.09%
1/1099 • 1 Year
|
|
Cardiac disorders
Atrial fibrillation
|
0.27%
3/1099 • 1 Year
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.27%
3/1099 • 1 Year
|
|
Cardiac disorders
Coronary artery disease
|
0.18%
2/1099 • 1 Year
|
|
Cardiac disorders
Sinus node dysfunction
|
0.18%
2/1099 • 1 Year
|
|
Cardiac disorders
Atrioventricular block complete
|
0.09%
1/1099 • 1 Year
|
|
Cardiac disorders
Cardiac failure
|
0.09%
1/1099 • 1 Year
|
|
Cardiac disorders
Heart valve stenosis
|
0.09%
1/1099 • 1 Year
|
|
Gastrointestinal disorders
Diarrhoea
|
0.18%
2/1099 • 1 Year
|
|
Gastrointestinal disorders
Gastritis
|
0.18%
2/1099 • 1 Year
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.18%
2/1099 • 1 Year
|
|
Gastrointestinal disorders
Constipation
|
0.09%
1/1099 • 1 Year
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.09%
1/1099 • 1 Year
|
|
Gastrointestinal disorders
Vomiting
|
0.09%
1/1099 • 1 Year
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.09%
1/1099 • 1 Year
|
|
Nervous system disorders
Cerebrovascular accident
|
0.09%
1/1099 • 1 Year
|
|
Nervous system disorders
Dementia of the Alzheimer's type, with delirium
|
0.09%
1/1099 • 1 Year
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.09%
1/1099 • 1 Year
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.09%
1/1099 • 1 Year
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.09%
1/1099 • 1 Year
|
|
Nervous system disorders
Seizure
|
0.09%
1/1099 • 1 Year
|
|
Nervous system disorders
Syncope
|
0.09%
1/1099 • 1 Year
|
|
Nervous system disorders
Transient ischaemic attack
|
0.09%
1/1099 • 1 Year
|
|
Psychiatric disorders
Delirium
|
0.18%
2/1099 • 1 Year
|
|
Psychiatric disorders
Psychotic disorder
|
0.18%
2/1099 • 1 Year
|
|
Psychiatric disorders
Agitation
|
0.09%
1/1099 • 1 Year
|
|
Psychiatric disorders
Delusion
|
0.09%
1/1099 • 1 Year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.45%
5/1099 • 1 Year
|
|
Vascular disorders
Deep vein thrombosis
|
0.18%
2/1099 • 1 Year
|
|
Vascular disorders
Aortic aneurysm
|
0.09%
1/1099 • 1 Year
|
|
Vascular disorders
Hypotension
|
0.09%
1/1099 • 1 Year
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.27%
3/1099 • 1 Year
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.09%
1/1099 • 1 Year
|
|
Renal and urinary disorders
Acute kidney injury
|
0.09%
1/1099 • 1 Year
|
|
Renal and urinary disorders
Renal failure
|
0.09%
1/1099 • 1 Year
|
|
Renal and urinary disorders
Urinary retention
|
0.09%
1/1099 • 1 Year
|
|
Blood and lymphatic system disorders
Anaemia
|
0.18%
2/1099 • 1 Year
|
|
General disorders
Hypothermia
|
0.09%
1/1099 • 1 Year
|
|
General disorders
Sudden death
|
0.09%
1/1099 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.18%
2/1099 • 1 Year
|
|
Investigations
Full blood count decreased
|
0.09%
1/1099 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.09%
1/1099 • 1 Year
|
|
Reproductive system and breast disorders
Cervix disorder
|
0.09%
1/1099 • 1 Year
|
|
Reproductive system and breast disorders
Cervix haemorrhage uterine
|
0.09%
1/1099 • 1 Year
|
Other adverse events
| Measure |
RVT-101 35 mg Tablets
n=1099 participants at risk
once daily, oral tablets
RVT-101 35 mg tablets: once daily, oral tablets
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.82%
9/1099 • 1 Year
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.18%
2/1099 • 1 Year
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.18%
2/1099 • 1 Year
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.09%
1/1099 • 1 Year
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.09%
1/1099 • 1 Year
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.27%
3/1099 • 1 Year
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.18%
2/1099 • 1 Year
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.09%
1/1099 • 1 Year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.27%
3/1099 • 1 Year
|
|
Cardiac disorders
Atrial flutter
|
0.09%
1/1099 • 1 Year
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.36%
4/1099 • 1 Year
|
|
Cardiac disorders
Bradycardia
|
0.18%
2/1099 • 1 Year
|
|
Cardiac disorders
Cardiac failure congestive
|
0.09%
1/1099 • 1 Year
|
|
Cardiac disorders
Mitral valve incompetence
|
0.09%
1/1099 • 1 Year
|
|
Cardiac disorders
Myocardial ischaemia
|
0.27%
3/1099 • 1 Year
|
|
Cardiac disorders
Palpitations
|
0.27%
3/1099 • 1 Year
|
|
Cardiac disorders
Sinus arrhythmia
|
0.09%
1/1099 • 1 Year
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.18%
2/1099 • 1 Year
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.09%
1/1099 • 1 Year
|
|
Ear and labyrinth disorders
Motion sickness
|
0.09%
1/1099 • 1 Year
|
|
Ear and labyrinth disorders
Vertigo
|
0.64%
7/1099 • 1 Year
|
|
Endocrine disorders
Hypothyroidism
|
0.27%
3/1099 • 1 Year
|
|
Endocrine disorders
Thyroid mass
|
0.09%
1/1099 • 1 Year
|
|
Eye disorders
Angle closure glaucoma
|
0.09%
1/1099 • 1 Year
|
|
Eye disorders
Blepharitis
|
0.09%
1/1099 • 1 Year
|
|
Eye disorders
Cataract
|
0.73%
8/1099 • 1 Year
|
|
Eye disorders
Dry eye
|
0.09%
1/1099 • 1 Year
|
|
Eye disorders
Macular degeneration
|
0.09%
1/1099 • 1 Year
|
|
Eye disorders
Ocular hyperaemia
|
0.09%
1/1099 • 1 Year
|
|
Eye disorders
Ocular rosacea
|
0.09%
1/1099 • 1 Year
|
|
Eye disorders
Retinal detachment
|
0.09%
1/1099 • 1 Year
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.09%
1/1099 • 1 Year
|
|
Gastrointestinal disorders
Abdominal distension
|
0.09%
1/1099 • 1 Year
|
|
Gastrointestinal disorders
Abdominal mass
|
0.09%
1/1099 • 1 Year
|
|
Gastrointestinal disorders
Abdominal pain
|
0.36%
4/1099 • 1 Year
|
|
Gastrointestinal disorders
Anal fissure
|
0.09%
1/1099 • 1 Year
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.09%
1/1099 • 1 Year
|
|
Gastrointestinal disorders
Constipation
|
0.45%
5/1099 • 1 Year
|
|
Gastrointestinal disorders
Dental caries
|
0.09%
1/1099 • 1 Year
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
17/1099 • 1 Year
|
|
Gastrointestinal disorders
Dry mouth
|
0.18%
2/1099 • 1 Year
|
|
Gastrointestinal disorders
Dyspepsia
|
0.27%
3/1099 • 1 Year
|
|
Gastrointestinal disorders
Faeces soft
|
0.09%
1/1099 • 1 Year
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.09%
1/1099 • 1 Year
|
|
Gastrointestinal disorders
Gastritis
|
0.09%
1/1099 • 1 Year
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.18%
2/1099 • 1 Year
|
|
Gastrointestinal disorders
Haematochezia
|
0.09%
1/1099 • 1 Year
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.27%
3/1099 • 1 Year
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.09%
1/1099 • 1 Year
|
|
Gastrointestinal disorders
Nausea
|
1.4%
15/1099 • 1 Year
|
|
Gastrointestinal disorders
Oral contusion
|
0.09%
1/1099 • 1 Year
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.09%
1/1099 • 1 Year
|
|
Gastrointestinal disorders
Toothache
|
0.27%
3/1099 • 1 Year
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.18%
2/1099 • 1 Year
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
13/1099 • 1 Year
|
|
General disorders
Asthenia
|
0.09%
1/1099 • 1 Year
|
|
General disorders
Catheter site haemorrhage
|
0.09%
1/1099 • 1 Year
|
|
General disorders
Chest pain
|
0.18%
2/1099 • 1 Year
|
|
General disorders
Facial pain
|
0.09%
1/1099 • 1 Year
|
|
General disorders
Fat necrosis
|
0.09%
1/1099 • 1 Year
|
|
General disorders
Fatigue
|
0.36%
4/1099 • 1 Year
|
|
General disorders
Feeling cold
|
0.09%
1/1099 • 1 Year
|
|
General disorders
Gait disturbance
|
0.55%
6/1099 • 1 Year
|
|
General disorders
Gravitational oedema
|
0.09%
1/1099 • 1 Year
|
|
General disorders
Hyperthermia
|
0.09%
1/1099 • 1 Year
|
|
General disorders
Influenza like illness
|
0.18%
2/1099 • 1 Year
|
|
General disorders
Non-cardiac chest pain
|
0.27%
3/1099 • 1 Year
|
|
General disorders
Oedema peripheral
|
0.73%
8/1099 • 1 Year
|
|
General disorders
Pyrexia
|
0.09%
1/1099 • 1 Year
|
|
General disorders
Thirst
|
0.09%
1/1099 • 1 Year
|
|
Hepatobiliary disorders
Cholecystitis
|
0.09%
1/1099 • 1 Year
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.09%
1/1099 • 1 Year
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.09%
1/1099 • 1 Year
|
|
Immune system disorders
Seasonal allergy
|
0.27%
3/1099 • 1 Year
|
|
Infections and infestations
Bacteriuria
|
0.09%
1/1099 • 1 Year
|
|
Infections and infestations
Bronchitis
|
1.1%
12/1099 • 1 Year
|
|
Infections and infestations
Bronchitis bacterial
|
0.09%
1/1099 • 1 Year
|
|
Infections and infestations
Cellulitis
|
0.09%
1/1099 • 1 Year
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.09%
1/1099 • 1 Year
|
|
Infections and infestations
Cystitis
|
0.09%
1/1099 • 1 Year
|
|
Infections and infestations
Fungal skin infection
|
0.09%
1/1099 • 1 Year
|
|
Infections and infestations
Gastroenteritis
|
0.55%
6/1099 • 1 Year
|
|
Infections and infestations
Gastroenteritis viral
|
0.09%
1/1099 • 1 Year
|
|
Infections and infestations
Helicobacter infection
|
0.09%
1/1099 • 1 Year
|
|
Infections and infestations
Herpes zoster
|
0.27%
3/1099 • 1 Year
|
|
Infections and infestations
Hordeolum
|
0.09%
1/1099 • 1 Year
|
|
Infections and infestations
Infected bite
|
0.09%
1/1099 • 1 Year
|
|
Infections and infestations
Infected dermal cyst
|
0.09%
1/1099 • 1 Year
|
|
Infections and infestations
Influenza
|
0.64%
7/1099 • 1 Year
|
|
Infections and infestations
Laryngitis
|
0.09%
1/1099 • 1 Year
|
|
Infections and infestations
Localised infection
|
0.09%
1/1099 • 1 Year
|
|
Infections and infestations
Lower respiratory tract infection
|
0.55%
6/1099 • 1 Year
|
|
Infections and infestations
Lyme disease
|
0.18%
2/1099 • 1 Year
|
|
Infections and infestations
Nasopharyngitis
|
2.1%
23/1099 • 1 Year
|
|
Infections and infestations
Onychomycosis
|
0.18%
2/1099 • 1 Year
|
|
Infections and infestations
Oral candidiasis
|
0.09%
1/1099 • 1 Year
|
|
Infections and infestations
Oral herpes
|
0.09%
1/1099 • 1 Year
|
|
Infections and infestations
Otitis media
|
0.09%
1/1099 • 1 Year
|
|
Infections and infestations
Paronychia
|
0.18%
2/1099 • 1 Year
|
|
Infections and infestations
Pharyngitis
|
0.09%
1/1099 • 1 Year
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.09%
1/1099 • 1 Year
|
|
Infections and infestations
Pneumonia
|
0.27%
3/1099 • 1 Year
|
|
Infections and infestations
Postoperative wound infection
|
0.09%
1/1099 • 1 Year
|
|
Infections and infestations
Pyuria
|
0.09%
1/1099 • 1 Year
|
|
Infections and infestations
Respiratory tract infection
|
0.09%
1/1099 • 1 Year
|
|
Infections and infestations
Root canal infection
|
0.09%
1/1099 • 1 Year
|
|
Infections and infestations
Sinusitis
|
0.18%
2/1099 • 1 Year
|
|
Infections and infestations
Tooth abscess
|
0.09%
1/1099 • 1 Year
|
|
Infections and infestations
Tooth infection
|
0.18%
2/1099 • 1 Year
|
|
Infections and infestations
Upper respiratory tract infection
|
1.6%
18/1099 • 1 Year
|
|
Infections and infestations
Urinary tract infection
|
4.1%
45/1099 • 1 Year
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.09%
1/1099 • 1 Year
|
|
Infections and infestations
Viral infection
|
0.09%
1/1099 • 1 Year
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.09%
1/1099 • 1 Year
|
|
Infections and infestations
Wound infection
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.18%
2/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.18%
2/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Asbestosis
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Concussion
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Confusion postoperative
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Contusion
|
0.91%
10/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Dose calculation error
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Face injury
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Fall
|
4.6%
51/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Frostbite
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.27%
3/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Head injury
|
0.45%
5/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.18%
2/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Laceration
|
0.18%
2/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.18%
2/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.18%
2/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.18%
2/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.18%
2/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.18%
2/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.55%
6/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.18%
2/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Splinter
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.27%
3/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Wound
|
0.18%
2/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.09%
1/1099 • 1 Year
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.18%
2/1099 • 1 Year
|
|
Investigations
Alanine aminotransferase increased
|
0.73%
8/1099 • 1 Year
|
|
Investigations
Aspartate aminotransferase increased
|
0.45%
5/1099 • 1 Year
|
|
Investigations
Blood alkaline phosphatase increased
|
0.82%
9/1099 • 1 Year
|
|
Investigations
Blood bilirubin increased
|
0.09%
1/1099 • 1 Year
|
|
Investigations
Blood cholesterol increased
|
0.09%
1/1099 • 1 Year
|
|
Investigations
Blood creatinine decreased
|
0.18%
2/1099 • 1 Year
|
|
Investigations
Blood creatinine increased
|
0.55%
6/1099 • 1 Year
|
|
Investigations
Blood electrolytes abnormal
|
0.09%
1/1099 • 1 Year
|
|
Investigations
Blood glucose increased
|
0.09%
1/1099 • 1 Year
|
|
Investigations
Blood potassium increased
|
0.18%
2/1099 • 1 Year
|
|
Investigations
Blood pressure increased
|
0.36%
4/1099 • 1 Year
|
|
Investigations
Blood urea increased
|
0.27%
3/1099 • 1 Year
|
|
Investigations
Blood urine present
|
0.18%
2/1099 • 1 Year
|
|
Investigations
Creatinine renal clearance decreased
|
1.4%
15/1099 • 1 Year
|
|
Investigations
Crystal urine
|
0.09%
1/1099 • 1 Year
|
|
Investigations
Crystal urine present
|
0.18%
2/1099 • 1 Year
|
|
Investigations
Electrocardiogram QT prolonged
|
0.18%
2/1099 • 1 Year
|
|
Investigations
Eosinophil count increased
|
0.09%
1/1099 • 1 Year
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.3%
14/1099 • 1 Year
|
|
Investigations
Glomerular filtration rate decreased
|
0.09%
1/1099 • 1 Year
|
|
Investigations
Haemoglobin decreased
|
0.09%
1/1099 • 1 Year
|
|
Investigations
Hepatic enzyme increased
|
0.09%
1/1099 • 1 Year
|
|
Investigations
Liver function test increased
|
0.27%
3/1099 • 1 Year
|
|
Investigations
Lymphocyte count decreased
|
0.73%
8/1099 • 1 Year
|
|
Investigations
Mammogram abnormal
|
0.09%
1/1099 • 1 Year
|
|
Investigations
Monocyte count increased
|
0.09%
1/1099 • 1 Year
|
|
Investigations
Neutrophil count decreased
|
0.09%
1/1099 • 1 Year
|
|
Investigations
Neutrophil count increased
|
0.27%
3/1099 • 1 Year
|
|
Investigations
Platelet count decreased
|
0.09%
1/1099 • 1 Year
|
|
Investigations
Protein urine present
|
0.09%
1/1099 • 1 Year
|
|
Investigations
Red blood cell count increased
|
0.09%
1/1099 • 1 Year
|
|
Investigations
Red blood cells urine
|
0.09%
1/1099 • 1 Year
|
|
Investigations
Transaminases increased
|
0.09%
1/1099 • 1 Year
|
|
Investigations
Urine analysis abnormal
|
0.36%
4/1099 • 1 Year
|
|
Investigations
Urine leukocyte esterase
|
0.09%
1/1099 • 1 Year
|
|
Investigations
Weight decreased
|
0.64%
7/1099 • 1 Year
|
|
Investigations
Weight increased
|
0.45%
5/1099 • 1 Year
|
|
Investigations
White blood cell count increased
|
0.09%
1/1099 • 1 Year
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.73%
8/1099 • 1 Year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.45%
5/1099 • 1 Year
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.18%
2/1099 • 1 Year
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.09%
1/1099 • 1 Year
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.09%
1/1099 • 1 Year
|
|
Metabolism and nutrition disorders
Food craving
|
0.09%
1/1099 • 1 Year
|
|
Metabolism and nutrition disorders
Gout
|
0.09%
1/1099 • 1 Year
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.09%
1/1099 • 1 Year
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.18%
2/1099 • 1 Year
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.18%
2/1099 • 1 Year
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.82%
9/1099 • 1 Year
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.09%
1/1099 • 1 Year
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.09%
1/1099 • 1 Year
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.09%
1/1099 • 1 Year
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.18%
2/1099 • 1 Year
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.18%
2/1099 • 1 Year
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.09%
1/1099 • 1 Year
|
|
Metabolism and nutrition disorders
Underweight
|
0.09%
1/1099 • 1 Year
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.09%
1/1099 • 1 Year
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.18%
2/1099 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.91%
10/1099 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.09%
1/1099 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
22/1099 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.09%
1/1099 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Extremity contracture
|
0.09%
1/1099 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.09%
1/1099 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc space narrowing
|
0.09%
1/1099 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.09%
1/1099 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.09%
1/1099 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
0.09%
1/1099 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.18%
2/1099 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.55%
6/1099 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.18%
2/1099 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.18%
2/1099 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.27%
3/1099 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.36%
4/1099 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.09%
1/1099 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.64%
7/1099 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.09%
1/1099 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.09%
1/1099 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.27%
3/1099 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
0.09%
1/1099 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.09%
1/1099 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.27%
3/1099 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.18%
2/1099 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiolipoma
|
0.09%
1/1099 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.09%
1/1099 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroma
|
0.09%
1/1099 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic granuloma
|
0.09%
1/1099 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.09%
1/1099 • 1 Year
|
|
Nervous system disorders
Apraxia
|
0.09%
1/1099 • 1 Year
|
|
Nervous system disorders
Areflexia
|
0.09%
1/1099 • 1 Year
|
|
Nervous system disorders
Balance disorder
|
0.09%
1/1099 • 1 Year
|
|
Nervous system disorders
Bradykinesia
|
0.09%
1/1099 • 1 Year
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.18%
2/1099 • 1 Year
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.09%
1/1099 • 1 Year
|
|
Nervous system disorders
Cognitive disorder
|
0.36%
4/1099 • 1 Year
|
|
Nervous system disorders
Decreased vibratory sense
|
0.27%
3/1099 • 1 Year
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.45%
5/1099 • 1 Year
|
|
Nervous system disorders
Dizziness
|
1.5%
17/1099 • 1 Year
|
|
Nervous system disorders
Dizziness postural
|
0.09%
1/1099 • 1 Year
|
|
Nervous system disorders
Dysaesthesia
|
0.09%
1/1099 • 1 Year
|
|
Nervous system disorders
Dysgeusia
|
0.09%
1/1099 • 1 Year
|
|
Nervous system disorders
Dyspraxia
|
0.09%
1/1099 • 1 Year
|
|
Nervous system disorders
Epilepsy
|
0.18%
2/1099 • 1 Year
|
|
Nervous system disorders
Facial paralysis
|
0.09%
1/1099 • 1 Year
|
|
Nervous system disorders
Gait apraxia
|
0.09%
1/1099 • 1 Year
|
|
Nervous system disorders
Headache
|
1.5%
17/1099 • 1 Year
|
|
Nervous system disorders
Hypertonia
|
0.09%
1/1099 • 1 Year
|
|
Nervous system disorders
Lethargy
|
0.09%
1/1099 • 1 Year
|
|
Nervous system disorders
Loss of consciousness
|
0.09%
1/1099 • 1 Year
|
|
Nervous system disorders
Memory impairment
|
0.09%
1/1099 • 1 Year
|
|
Nervous system disorders
Myoclonus
|
0.09%
1/1099 • 1 Year
|
|
Nervous system disorders
Paraesthesia
|
0.09%
1/1099 • 1 Year
|
|
Nervous system disorders
Parkinsonian gait
|
0.09%
1/1099 • 1 Year
|
|
Nervous system disorders
Parkinsonism
|
0.27%
3/1099 • 1 Year
|
|
Nervous system disorders
Postural tremor
|
0.09%
1/1099 • 1 Year
|
|
Nervous system disorders
Presyncope
|
0.09%
1/1099 • 1 Year
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.09%
1/1099 • 1 Year
|
|
Nervous system disorders
Somnolence
|
0.18%
2/1099 • 1 Year
|
|
Nervous system disorders
Syncope
|
0.55%
6/1099 • 1 Year
|
|
Nervous system disorders
Tension headache
|
0.09%
1/1099 • 1 Year
|
|
Nervous system disorders
Transient ischaemic attack
|
0.18%
2/1099 • 1 Year
|
|
Nervous system disorders
Tremor
|
0.36%
4/1099 • 1 Year
|
|
Psychiatric disorders
Abnormal behaviour
|
0.45%
5/1099 • 1 Year
|
|
Psychiatric disorders
Abnormal dreams
|
0.18%
2/1099 • 1 Year
|
|
Psychiatric disorders
Adjustment disorder with mixed anxiety and depressed mood
|
0.09%
1/1099 • 1 Year
|
|
Psychiatric disorders
Aggression
|
0.73%
8/1099 • 1 Year
|
|
Psychiatric disorders
Agitation
|
1.5%
17/1099 • 1 Year
|
|
Psychiatric disorders
Anxiety
|
1.5%
16/1099 • 1 Year
|
|
Psychiatric disorders
Confusional state
|
0.64%
7/1099 • 1 Year
|
|
Psychiatric disorders
Delirium
|
0.09%
1/1099 • 1 Year
|
|
Psychiatric disorders
Delusion
|
0.64%
7/1099 • 1 Year
|
|
Psychiatric disorders
Depressed mood
|
0.45%
5/1099 • 1 Year
|
|
Psychiatric disorders
Depression
|
1.3%
14/1099 • 1 Year
|
|
Psychiatric disorders
Disorientation
|
0.27%
3/1099 • 1 Year
|
|
Psychiatric disorders
Dysphemia
|
0.09%
1/1099 • 1 Year
|
|
Psychiatric disorders
Encopresis
|
0.09%
1/1099 • 1 Year
|
|
Psychiatric disorders
Enuresis
|
0.09%
1/1099 • 1 Year
|
|
Psychiatric disorders
Frustration tolerance decreased
|
0.18%
2/1099 • 1 Year
|
|
Psychiatric disorders
Hallucination
|
0.36%
4/1099 • 1 Year
|
|
Psychiatric disorders
Hallucination, olfactory
|
0.09%
1/1099 • 1 Year
|
|
Psychiatric disorders
Hallucination, visual
|
0.55%
6/1099 • 1 Year
|
|
Psychiatric disorders
Insomnia
|
0.73%
8/1099 • 1 Year
|
|
Psychiatric disorders
Irritability
|
1.0%
11/1099 • 1 Year
|
|
Psychiatric disorders
Libido decreased
|
0.09%
1/1099 • 1 Year
|
|
Psychiatric disorders
Mental status changes
|
0.09%
1/1099 • 1 Year
|
|
Psychiatric disorders
Mood altered
|
0.18%
2/1099 • 1 Year
|
|
Psychiatric disorders
Mood swings
|
0.09%
1/1099 • 1 Year
|
|
Psychiatric disorders
Nervousness
|
0.09%
1/1099 • 1 Year
|
|
Psychiatric disorders
Neuropsychiatric symptoms
|
0.09%
1/1099 • 1 Year
|
|
Psychiatric disorders
Nightmare
|
0.09%
1/1099 • 1 Year
|
|
Psychiatric disorders
Panic attack
|
0.18%
2/1099 • 1 Year
|
|
Psychiatric disorders
Paranoia
|
0.18%
2/1099 • 1 Year
|
|
Psychiatric disorders
Psychotic disorder
|
0.09%
1/1099 • 1 Year
|
|
Psychiatric disorders
Restlessness
|
0.27%
3/1099 • 1 Year
|
|
Psychiatric disorders
Sleep disorder
|
0.45%
5/1099 • 1 Year
|
|
Psychiatric disorders
Suicidal ideation
|
0.45%
5/1099 • 1 Year
|
|
Psychiatric disorders
Suspiciousness
|
0.09%
1/1099 • 1 Year
|
|
Psychiatric disorders
Tearfulness
|
0.18%
2/1099 • 1 Year
|
|
Renal and urinary disorders
Calculus bladder
|
0.09%
1/1099 • 1 Year
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.18%
2/1099 • 1 Year
|
|
Renal and urinary disorders
Haematuria
|
0.36%
4/1099 • 1 Year
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.09%
1/1099 • 1 Year
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.09%
1/1099 • 1 Year
|
|
Renal and urinary disorders
Pollakiuria
|
0.36%
4/1099 • 1 Year
|
|
Renal and urinary disorders
Polyuria
|
0.18%
2/1099 • 1 Year
|
|
Renal and urinary disorders
Renal cyst
|
0.18%
2/1099 • 1 Year
|
|
Renal and urinary disorders
Renal failure
|
0.27%
3/1099 • 1 Year
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.27%
3/1099 • 1 Year
|
|
Renal and urinary disorders
Urethral fistula
|
0.09%
1/1099 • 1 Year
|
|
Renal and urinary disorders
Urinary incontinence
|
1.1%
12/1099 • 1 Year
|
|
Renal and urinary disorders
Urinary retention
|
0.09%
1/1099 • 1 Year
|
|
Reproductive system and breast disorders
Atrophic vulvovaginitis
|
0.09%
1/1099 • 1 Year
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.18%
2/1099 • 1 Year
|
|
Reproductive system and breast disorders
Breast haematoma
|
0.09%
1/1099 • 1 Year
|
|
Reproductive system and breast disorders
Cervix disorder
|
0.09%
1/1099 • 1 Year
|
|
Reproductive system and breast disorders
Fibrocystic breast disease
|
0.09%
1/1099 • 1 Year
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.09%
1/1099 • 1 Year
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.09%
1/1099 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.09%
1/1099 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.09%
1/1099 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.09%
1/1099 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.18%
2/1099 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.18%
2/1099 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.91%
10/1099 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.36%
4/1099 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.18%
2/1099 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.36%
4/1099 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.09%
1/1099 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.27%
3/1099 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.09%
1/1099 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.18%
2/1099 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.09%
1/1099 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.09%
1/1099 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.09%
1/1099 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Alopecia areata
|
0.09%
1/1099 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.27%
3/1099 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.09%
1/1099 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.18%
2/1099 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.18%
2/1099 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.18%
2/1099 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
0.09%
1/1099 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.09%
1/1099 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.09%
1/1099 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.18%
2/1099 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.09%
1/1099 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.09%
1/1099 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.09%
1/1099 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.09%
1/1099 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.18%
2/1099 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.55%
6/1099 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.27%
3/1099 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.09%
1/1099 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.09%
1/1099 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.18%
2/1099 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.45%
5/1099 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.09%
1/1099 • 1 Year
|
|
Vascular disorders
Arteriosclerosis
|
0.09%
1/1099 • 1 Year
|
|
Vascular disorders
Blood pressure fluctuation
|
0.09%
1/1099 • 1 Year
|
|
Vascular disorders
Deep vein thrombosis
|
0.09%
1/1099 • 1 Year
|
|
Vascular disorders
Flushing
|
0.09%
1/1099 • 1 Year
|
|
Vascular disorders
Haematoma
|
0.18%
2/1099 • 1 Year
|
|
Vascular disorders
Hot flush
|
0.27%
3/1099 • 1 Year
|
|
Vascular disorders
Hypertension
|
0.91%
10/1099 • 1 Year
|
|
Vascular disorders
Hypotension
|
0.27%
3/1099 • 1 Year
|
|
Vascular disorders
Orthostatic hypertension
|
0.09%
1/1099 • 1 Year
|
|
Vascular disorders
Orthostatic hypotension
|
0.18%
2/1099 • 1 Year
|
|
Vascular disorders
Peripheral vascular disorder
|
0.09%
1/1099 • 1 Year
|
|
Vascular disorders
Peripheral venous disease
|
0.09%
1/1099 • 1 Year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place