Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-25 @ 8:32 PM
NCT ID:
NCT02730169
Description:
The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Frequency Threshold:
0
Time Frame:
After randomisation and up to 90 days after the last administration of study drug.
Study:
NCT02730169
Study Brief:
Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| BGS649 0.1 mg | BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks | 0 | None | 2 | 67 | 37 | 67 | View |
| BGS649 0.3 mg | BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks | 0 | None | 2 | 66 | 39 | 66 | View |
| BGS649 1.0 mg | BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks | 0 | None | 5 | 67 | 47 | 67 | View |
| Placebo | Placebo weekly (3 indistinguishable placebo capsules) Placebo: Capsules will be taken weekly for a maximum of 24 weeks | 0 | None | 5 | 71 | 41 | 71 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Postoperative wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Arthritis infective | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Diverticulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Osteomyelitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Pyelonephritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Multiple organ dysfunction syndrome | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Cardiac arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.1) | View |
| Pericardial effusion | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.1) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Gouty arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Acute kidney injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.1) | View |
| Ureterolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.1) | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (20.1) | View |
| Intestinal perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Skull fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Diabetic foot | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.1) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Folliculitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Furuncle | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Gastritis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Gastroenteritis norovirus | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Lower respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Oral herpes | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Otitis externa | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Otitis media | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Otitis media acute | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Rash pustular | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Tinea pedis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Viral upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Haematocrit increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.1) | View |
| Prostatic specific antigen increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.1) | View |
| Blood triglycerides increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.1) | View |
| Weight increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.1) | View |
| Blood creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.1) | View |
| Blood pressure increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.1) | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.1) | View |
| Hepatic enzyme increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.1) | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.1) | View |
| Blood bilirubin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.1) | View |
| Blood glucose increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.1) | View |
| C-reactive protein increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.1) | View |
| Electrocardiogram QT prolonged | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.1) | View |
| Glycosylated haemoglobin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.1) | View |
| Heart rate irregular | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.1) | View |
| Low density lipoprotein increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.1) | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Osteopenia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Bursitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Groin pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Intervertebral disc protrusion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Central nervous system lesion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Complex regional pain syndrome | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Facial paralysis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Lethargy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Metabolic encephalopathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Neuralgia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Presyncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Primary headache associated with sexual activity | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Sensory loss | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Tremor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Abdominal discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Dry mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Toothache | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Abdominal distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Food poisoning | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Haematochezia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Chest discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Cyst | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Energy increased | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.1) | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.1) | View |
| Libido decreased | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.1) | View |
| Irritability | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.1) | View |
| Adjustment disorder with depressed mood | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.1) | View |
| Agitation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.1) | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.1) | View |
| Apathy | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.1) | View |
| Euphoric mood | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.1) | View |
| Loss of libido | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.1) | View |
| Mood altered | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.1) | View |
| Back injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Excoriation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Laceration | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Procedural pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Radius fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Skin abrasion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Tendon rupture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Thermal burn | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Tooth fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Vitamin D deficiency | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.1) | View |
| Diabetes mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.1) | View |
| Hypertriglyceridaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.1) | View |
| Type 2 diabetes mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.1) | View |
| Fluid retention | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.1) | View |
| Gout | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.1) | View |
| Hypochloraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.1) | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.1) | View |
| Dermatitis contact | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.1) | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.1) | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.1) | View |
| Androgenetic alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.1) | View |
| Blister | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.1) | View |
| Dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.1) | View |
| Diabetic foot | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.1) | View |
| Hidradenitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.1) | View |
| Night sweats | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.1) | View |
| Onycholysis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.1) | View |
| Penile ulceration | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.1) | View |
| Seborrhoea | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.1) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Pickwickian syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Productive cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Rhinitis allergic | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Sinus congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Sleep apnoea syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Pollakiuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.1) | View |
| Nephrolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.1) | View |
| Bladder outlet obstruction | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.1) | View |
| Calculus urinary | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.1) | View |
| Chronic kidney disease | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.1) | View |
| Glycosuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.1) | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.1) | View |
| Hydronephrosis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.1) | View |
| Micturition urgency | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.1) | View |
| Nocturia | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.1) | View |
| Urinary retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.1) | View |
| Urinary tract obstruction | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.1) | View |
| Erectile dysfunction | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (20.1) | View |
| Gynaecomastia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (20.1) | View |
| Testicular pain | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (20.1) | View |
| Breast pain | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (20.1) | View |
| Erection increased | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (20.1) | View |
| Prostatic mass | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (20.1) | View |
| Prostatomegaly | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (20.1) | View |
| Spontaneous penile erection | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (20.1) | View |
| Testicular hypertrophy | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (20.1) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.1) | View |
| Haematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.1) | View |
| Hot flush | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.1) | View |
| Polycythaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (20.1) | View |
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.1) | View |
| Cyanosis | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.1) | View |
| Extrasystoles | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.1) | View |
| Dry eye | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (20.1) | View |
| Blepharitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (20.1) | View |
| Basal cell carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | View |
| Seborrhoeic keratosis | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | View |
| Squamous cell carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | View |
| Tinnitus | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (20.1) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Osteomyelitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Tooth abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Tooth infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Bacterial prostatitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Ear infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Blood insulin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.1) | View |
| Blood pressure decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.1) | View |
| Blood prolactin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.1) | View |
| Blood urine present | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.1) | View |
| Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Psoriatic arthropathy | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Rotator cuff syndrome | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Spinal column stenosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Trigger finger | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Feeling hot | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Non-cardiac chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Limb injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Muscle strain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Animal bite | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Arthropod sting | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Hypoglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.1) | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.1) | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.1) | View |
| Increased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.1) | View |
| Asthma | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Bronchial hyperreactivity | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Renal cyst | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.1) | View |
| Left ventricular hypertrophy | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.1) | View |