Trial Outcomes & Findings for Pletaal SR Post Marketing Observational Study (NCT NCT01782833)
NCT ID: NCT01782833
Last Updated: 2019-03-01
Results Overview
Incidence rates of overall AEs and ADRs that occurred during the study period
Recruitment status
COMPLETED
Target enrollment
3635 participants
Primary outcome timeframe
Follow-up at least once from baseline to 16 weeks
Results posted on
2019-03-01
Participant Flow
Participant milestones
| Measure |
Pletaal® SR Capsule
Patients who were receiving or planned to receive Pletaal® SR Capsule according to investigator's medical judgement after a written contract with the study site and provided a written consent to use personal information.
|
|---|---|
|
Overall Study
STARTED
|
3635
|
|
Overall Study
COMPLETED
|
3365
|
|
Overall Study
NOT COMPLETED
|
270
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pletaal SR Post Marketing Observational Study
Baseline characteristics by cohort
| Measure |
Pletaal® SR Capsule
n=3365 Participants
Subjects who received at least 1 dose of Pletaal® SR Capsule during the study period and had follow-up for safety assessment.
|
|---|---|
|
Age, Continuous
|
66.27 years
STANDARD_DEVIATION 10.92 • n=99 Participants
|
|
Sex: Female, Male
Female
|
1920 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
1445 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Follow-up at least once from baseline to 16 weeksIncidence rates of overall AEs and ADRs that occurred during the study period
Outcome measures
| Measure |
Pletaal® SR Capsule
n=3365 Participants
Patients who were receiving or planned to receive Pletaal® SR Capsule according to investigator's medical judgement after a written contract with the study site and provided a written consent to use personal information.
|
|---|---|
|
The Incidence Rate and the Number of AE/ADRs
Number of patients reported for AE
|
446 Participants
|
|
The Incidence Rate and the Number of AE/ADRs
Number of patients reported for ADR
|
155 Participants
|
SECONDARY outcome
Timeframe: Follow-up at least once from baseline to 16 weeksOutcome measures
| Measure |
Pletaal® SR Capsule
n=3365 Participants
Patients who were receiving or planned to receive Pletaal® SR Capsule according to investigator's medical judgement after a written contract with the study site and provided a written consent to use personal information.
|
|---|---|
|
The Incidence Rate of Tarchycardia and Palpitation After Pletaal® SR Capsule Administration
Number of patients reported for 'Tachycardia'
|
5 Participants
|
|
The Incidence Rate of Tarchycardia and Palpitation After Pletaal® SR Capsule Administration
Number of patients reported for 'Palpitat
|
19 Participants
|
SECONDARY outcome
Timeframe: Follow-up at least once from baseline to 16 weeksOutcome measures
| Measure |
Pletaal® SR Capsule
n=3365 Participants
Patients who were receiving or planned to receive Pletaal® SR Capsule according to investigator's medical judgement after a written contract with the study site and provided a written consent to use personal information.
|
|---|---|
|
The Number and Percentage of Drop-out Patients According to Aes
|
147 Participants
|
Adverse Events
Pletaal® SR Capsule
Serious events: 74 serious events
Other events: 372 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pletaal® SR Capsule
n=3365 participants at risk
Subjects who received at least 1 dose of Pletaal® SR Capsule during the study period and had follow-up for safety assessment.
|
|---|---|
|
Nervous system disorders
Cerebral infarction
|
0.15%
5/3365 • Number of events 5
|
|
Nervous system disorders
Dizziness
|
0.09%
3/3365 • Number of events 3
|
|
Nervous system disorders
Cerebrovascular accident
|
0.06%
2/3365 • Number of events 2
|
|
Nervous system disorders
Headache
|
0.06%
2/3365 • Number of events 2
|
|
Nervous system disorders
Transient ischaemic attack
|
0.06%
2/3365 • Number of events 2
|
|
Nervous system disorders
Central pain syndrome
|
0.03%
1/3365 • Number of events 1
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.03%
1/3365 • Number of events 1
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.03%
1/3365 • Number of events 1
|
|
Nervous system disorders
Dysarthria
|
0.03%
1/3365 • Number of events 1
|
|
Nervous system disorders
Hemiparesis
|
0.03%
1/3365 • Number of events 1
|
|
Nervous system disorders
Intracranial artery dissection
|
0.03%
1/3365 • Number of events 1
|
|
Nervous system disorders
Loss of consciousness
|
0.03%
1/3365 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
0.03%
1/3365 • Number of events 1
|
|
Nervous system disorders
Status epilepticus
|
0.03%
1/3365 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.15%
5/3365 • Number of events 5
|
|
Infections and infestations
Cellulitis
|
0.03%
1/3365 • Number of events 1
|
|
Infections and infestations
Lung abscess
|
0.03%
1/3365 • Number of events 1
|
|
Infections and infestations
Pyelonephritis acute
|
0.03%
1/3365 • Number of events 1
|
|
Infections and infestations
Pyometra
|
0.03%
1/3365 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.03%
1/3365 • Number of events 1
|
|
Gastrointestinal disorders
Haematemesis
|
0.03%
1/3365 • Number of events 1
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.03%
1/3365 • Number of events 1
|
|
Gastrointestinal disorders
Melaena
|
0.03%
1/3365 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.03%
1/3365 • Number of events 1
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.03%
1/3365 • Number of events 1
|
|
General disorders
Chest pain
|
0.06%
2/3365 • Number of events 2
|
|
General disorders
Asthenia
|
0.03%
1/3365 • Number of events 1
|
|
General disorders
Chest discomfort
|
0.03%
1/3365 • Number of events 1
|
|
General disorders
Oedema
|
0.03%
1/3365 • Number of events 1
|
|
Hepatobiliary disorders
Cholangitis
|
0.06%
2/3365 • Number of events 2
|
|
Hepatobiliary disorders
Cholecystitis
|
0.03%
1/3365 • Number of events 1
|
|
General disorders
Cholelithiasis
|
0.03%
1/3365 • Number of events 1
|
|
General disorders
Cholelithiasis obstructive
|
0.03%
1/3365 • Number of events 1
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.03%
1/3365 • Number of events 1
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.03%
1/3365 • Number of events 1
|
|
Injury, poisoning and procedural complications
Pneumoconiosis
|
0.03%
1/3365 • Number of events 1
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.03%
1/3365 • Number of events 1
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.03%
1/3365 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.03%
1/3365 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.03%
1/3365 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.03%
1/3365 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.03%
1/3365 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.03%
1/3365 • Number of events 1
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.06%
2/3365 • Number of events 2
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.03%
1/3365 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.03%
1/3365 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.03%
1/3365 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.03%
1/3365 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.03%
1/3365 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer
|
0.03%
1/3365 • Number of events 1
|
|
Cardiac disorders
Angina pectoris
|
0.06%
2/3365 • Number of events 2
|
|
Cardiac disorders
Coronary artery stenosis
|
0.03%
1/3365 • Number of events 1
|
|
Surgical and medical procedures
Intervertebral disc operation
|
0.03%
1/3365 • Number of events 1
|
|
Surgical and medical procedures
Intraocular lens implant
|
0.03%
1/3365 • Number of events 1
|
|
Surgical and medical procedures
Peritoneal dialysis
|
0.03%
1/3365 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.03%
1/3365 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.03%
1/3365 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.06%
2/3365 • Number of events 2
|
|
Vascular disorders
Diabetic vascular disorder
|
0.03%
1/3365 • Number of events 1
|
|
Vascular disorders
Shock
|
0.03%
1/3365 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia
|
0.03%
1/3365 • Number of events 1
|
|
Eye disorders
Diabetic retinopathy
|
0.03%
1/3365 • Number of events 1
|
|
Investigations
Weight decreased
|
0.03%
1/3365 • Number of events 1
|
|
Psychiatric disorders
Anxiety disorder
|
0.03%
1/3365 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.03%
1/3365 • Number of events 1
|
Other adverse events
| Measure |
Pletaal® SR Capsule
n=3365 participants at risk
Subjects who received at least 1 dose of Pletaal® SR Capsule during the study period and had follow-up for safety assessment.
|
|---|---|
|
Nervous system disorders
Headache
|
2.7%
91/3365 • Number of events 91
|
|
Nervous system disorders
Dizziness
|
1.2%
42/3365 • Number of events 42
|
|
Nervous system disorders
Paraesthesia
|
0.24%
8/3365 • Number of events 8
|
|
Nervous system disorders
Hypoaesthesia
|
0.21%
7/3365 • Number of events 7
|
|
Nervous system disorders
Cerebral infarction
|
0.03%
1/3365 • Number of events 1
|
|
Nervous system disorders
Migraine
|
0.09%
3/3365 • Number of events 3
|
|
Nervous system disorders
Amnesia
|
0.06%
2/3365 • Number of events 2
|
|
Nervous system disorders
Dizziness postural
|
0.06%
2/3365 • Number of events 2
|
|
Nervous system disorders
Hemiparesis
|
0.03%
1/3365 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.06%
2/3365 • Number of events 2
|
|
Nervous system disorders
Cerebellar ataxia
|
0.03%
1/3365 • Number of events 1
|
|
Nervous system disorders
Cervicogenic headache
|
0.03%
1/3365 • Number of events 1
|
|
Nervous system disorders
Complex regional pain syndrome
|
0.03%
1/3365 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.03%
1/3365 • Number of events 1
|
|
Nervous system disorders
Resting tremor
|
0.03%
1/3365 • Number of events 1
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.03%
1/3365 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.51%
17/3365 • Number of events 17
|
|
Gastrointestinal disorders
Dyspepsia
|
0.27%
9/3365 • Number of events 9
|
|
Gastrointestinal disorders
Nausea
|
0.21%
7/3365 • Number of events 7
|
|
Gastrointestinal disorders
Vomiting
|
0.24%
8/3365 • Number of events 8
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.18%
6/3365 • Number of events 6
|
|
Gastrointestinal disorders
Constipation
|
0.12%
4/3365 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal pain
|
0.06%
2/3365 • Number of events 2
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.06%
2/3365 • Number of events 2
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.06%
2/3365 • Number of events 2
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.06%
2/3365 • Number of events 2
|
|
Gastrointestinal disorders
Melaena
|
0.03%
1/3365 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.03%
1/3365 • Number of events 1
|
|
Gastrointestinal disorders
Anal pruritus
|
0.03%
1/3365 • Number of events 1
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.03%
1/3365 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.03%
1/3365 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.03%
1/3365 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.03%
1/3365 • Number of events 1
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.03%
1/3365 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.03%
1/3365 • Number of events 1
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.03%
1/3365 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
0.03%
1/3365 • Number of events 1
|
|
General disorders
Oedema
|
0.27%
9/3365 • Number of events 9
|
|
General disorders
Chest pain
|
0.06%
2/3365 • Number of events 2
|
|
General disorders
Oedema peripheral
|
0.12%
4/3365 • Number of events 4
|
|
General disorders
Chest discomfort
|
0.06%
2/3365 • Number of events 2
|
|
General disorders
Pain
|
0.09%
3/3365 • Number of events 3
|
|
General disorders
Asthenia
|
0.03%
1/3365 • Number of events 1
|
|
General disorders
Face oedema
|
0.06%
2/3365 • Number of events 2
|
|
General disorders
General symptom
|
0.03%
1/3365 • Number of events 1
|
|
General disorders
Generalised oedema
|
0.03%
1/3365 • Number of events 1
|
|
General disorders
Localised oedema
|
0.03%
1/3365 • Number of events 1
|
|
General disorders
Peripheral swelling
|
0.03%
1/3365 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.09%
3/3365 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.18%
6/3365 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.18%
6/3365 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.06%
2/3365 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.06%
2/3365 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.06%
2/3365 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.06%
2/3365 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.03%
1/3365 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.03%
1/3365 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.03%
1/3365 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.03%
1/3365 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myofascial pain syndrome
|
0.03%
1/3365 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.03%
1/3365 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.03%
1/3365 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.03%
1/3365 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.03%
1/3365 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.03%
1/3365 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
0.18%
6/3365 • Number of events 6
|
|
Infections and infestations
Pneumonia
|
0.03%
1/3365 • Number of events 1
|
|
Infections and infestations
Pyelonephritis acute
|
0.03%
1/3365 • Number of events 1
|
|
Infections and infestations
Periodontitis
|
0.06%
2/3365 • Number of events 2
|
|
Infections and infestations
Sinusitis
|
0.06%
2/3365 • Number of events 2
|
|
Infections and infestations
Upper respiratory tract infection
|
0.06%
2/3365 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
0.06%
2/3365 • Number of events 2
|
|
Infections and infestations
Chronic sinusitis
|
0.03%
1/3365 • Number of events 1
|
|
Infections and infestations
Periorbital cellulitis
|
0.03%
1/3365 • Number of events 1
|
|
Infections and infestations
Tinea pedis
|
0.03%
1/3365 • Number of events 1
|
|
Infections and infestations
Tooth abscess
|
0.03%
1/3365 • Number of events 1
|
|
Infections and infestations
Vestibular neuronitis
|
0.03%
1/3365 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
0.56%
19/3365 • Number of events 19
|
|
Cardiac disorders
Tachycardia
|
0.15%
5/3365 • Number of events 5
|
|
Cardiac disorders
Arrhythmia
|
0.03%
1/3365 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.03%
1/3365 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.12%
4/3365 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.12%
4/3365 • Number of events 4
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.06%
2/3365 • Number of events 2
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.06%
2/3365 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.06%
2/3365 • Number of events 2
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.03%
1/3365 • Number of events 1
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.03%
1/3365 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.03%
1/3365 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.03%
1/3365 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.21%
7/3365 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.09%
3/3365 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Chloasma
|
0.03%
1/3365 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.03%
1/3365 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.03%
1/3365 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.03%
1/3365 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.03%
1/3365 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.03%
1/3365 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.03%
1/3365 • Number of events 1
|
|
Investigations
Blood glucose increased
|
0.12%
4/3365 • Number of events 4
|
|
Investigations
Liver function test abnormal
|
0.06%
2/3365 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
0.03%
1/3365 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
0.03%
1/3365 • Number of events 1
|
|
Investigations
Bacterial test
|
0.03%
1/3365 • Number of events 1
|
|
Investigations
Blood glucose abnormal
|
0.03%
1/3365 • Number of events 1
|
|
Investigations
Blood pressure decreased
|
0.03%
1/3365 • Number of events 1
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.03%
1/3365 • Number of events 1
|
|
Investigations
Hepatic enzyme abnormal
|
0.03%
1/3365 • Number of events 1
|
|
Investigations
International normalised ratio increased
|
0.03%
1/3365 • Number of events 1
|
|
Investigations
Lipids increased
|
0.03%
1/3365 • Number of events 1
|
|
Investigations
Low density lipoprotein increased
|
0.03%
1/3365 • Number of events 1
|
|
Investigations
Urobilinogen urine increased
|
0.03%
1/3365 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.18%
6/3365 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.12%
4/3365 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.03%
1/3365 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.03%
1/3365 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.03%
1/3365 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.06%
2/3365 • Number of events 2
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.03%
1/3365 • Number of events 1
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.03%
1/3365 • Number of events 1
|
|
Injury, poisoning and procedural complications
Accident
|
0.03%
1/3365 • Number of events 1
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.03%
1/3365 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
0.03%
1/3365 • Number of events 1
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.03%
1/3365 • Number of events 1
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.03%
1/3365 • Number of events 1
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.03%
1/3365 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.21%
7/3365 • Number of events 7
|
|
Psychiatric disorders
Anxiety
|
0.06%
2/3365 • Number of events 2
|
|
Psychiatric disorders
Delirium
|
0.03%
1/3365 • Number of events 1
|
|
Psychiatric disorders
Dysthymic disorder
|
0.03%
1/3365 • Number of events 1
|
|
Psychiatric disorders
Hallucination, auditory
|
0.03%
1/3365 • Number of events 1
|
|
Psychiatric disorders
Mood altered
|
0.03%
1/3365 • Number of events 1
|
|
Psychiatric disorders
Sleep disorder
|
0.03%
1/3365 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
0.18%
6/3365 • Number of events 6
|
|
Ear and labyrinth disorders
Tinnitus
|
0.09%
3/3365 • Number of events 3
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.09%
3/3365 • Number of events 3
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.03%
1/3365 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
0.09%
3/3365 • Number of events 3
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.06%
2/3365 • Number of events 2
|
|
Renal and urinary disorders
Azotaemia
|
0.03%
1/3365 • Number of events 1
|
|
Renal and urinary disorders
Bladder hypertrophy
|
0.03%
1/3365 • Number of events 1
|
|
Renal and urinary disorders
Calculus ureteric
|
0.03%
1/3365 • Number of events 1
|
|
Renal and urinary disorders
Calculus urinary
|
0.03%
1/3365 • Number of events 1
|
|
Renal and urinary disorders
Dysuria
|
0.03%
1/3365 • Number of events 1
|
|
Renal and urinary disorders
Urethral stenosis
|
0.03%
1/3365 • Number of events 1
|
|
Vascular disorders
Peripheral coldness
|
0.06%
2/3365 • Number of events 3
|
|
Vascular disorders
Hypertension
|
0.06%
2/3365 • Number of events 2
|
|
Vascular disorders
Flushing
|
0.03%
1/3365 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.03%
1/3365 • Number of events 1
|
|
Vascular disorders
Orthostatic hypotension
|
0.03%
1/3365 • Number of events 1
|
|
Vascular disorders
Thrombophlebitis
|
0.03%
1/3365 • Number of events 1
|
|
Eye disorders
Cataract
|
0.06%
2/3365 • Number of events 2
|
|
Eye disorders
Diabetic retinopathy
|
0.03%
1/3365 • Number of events 1
|
|
Eye disorders
Dacryostenosis acquired
|
0.03%
1/3365 • Number of events 1
|
|
Eye disorders
Diplopia
|
0.03%
1/3365 • Number of events 1
|
|
Eye disorders
Dry eye
|
0.03%
1/3365 • Number of events 1
|
|
Eye disorders
Keratitis
|
0.03%
1/3365 • Number of events 1
|
|
Eye disorders
Macular fibrosis
|
0.03%
1/3365 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.03%
1/3365 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.03%
1/3365 • Number of events 1
|
|
Surgical and medical procedures
Tooth extraction
|
0.06%
2/3365 • Number of events 2
|
|
Surgical and medical procedures
Polypectomy
|
0.03%
1/3365 • Number of events 1
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.06%
2/3365 • Number of events 2
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.06%
2/3365 • Number of events 2
|
|
Reproductive system and breast disorders
Breast pain
|
0.03%
1/3365 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia
|
0.03%
1/3365 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place