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:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
NCT ID:
NCT02959918
Description:
None
Frequency Threshold:
5
Time Frame:
5 months
Study:
NCT02959918
Study Brief:
Multi-Dose Safety/Pharmacodynamic Study of SEL-212/SEL-037 in Subjects With Symptomatic Gout & Elevated Blood Uric Acid
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| SEL-037 (Pegadricase) Low Dose | Pegadricase 0.2 mg/kg IV every 28 days for up to 5 doses | 0 | None | 1 | 3 | 3 | 3 | View |
| SEL-037 (Pegadricase) High Dose | Pegadricase 0.4 mg/kg IV every 28 days for up to 5 doses | 0 | None | 1 | 3 | 3 | 3 | View |
| SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses | SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg IV every 28 days for 2 doses | 0 | None | 2 | 9 | 8 | 9 | View |
| SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses | SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.4 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg IV every 28 days for 2 doses | 0 | None | 0 | 10 | 8 | 10 | View |
| SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses | SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg IV every 28 days for 2 doses | 0 | None | 0 | 6 | 6 | 6 | View |
| SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses | SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.4 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg IV every 28 days for 2 doses | 0 | None | 1 | 11 | 10 | 11 | View |
| SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses | SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg IV every 28 days for 2 doses | 0 | None | 2 | 11 | 10 | 11 | View |
| SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses | SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.4 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg IV every 28 days for 2 doses | 0 | None | 4 | 12 | 12 | 12 | View |
| SEL-212: SEL-110 (0.125 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses | SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.125 mg/kg + Pegadricase 0.4 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg IV every 28 days for 2 doses | 0 | None | 2 | 14 | 14 | 14 | View |
| SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses | SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg IV every 28 days for 2 doses | 0 | None | 0 | 13 | 12 | 13 | View |
| SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses | SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.4 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg IV every 28 days for 2 doses | 0 | None | 1 | 14 | 14 | 14 | View |
| SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 5 Doses | SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 5 doses | 0 | None | 3 | 23 | 21 | 23 | View |
| SEL-212: SEL-110 0.15 mg/kg + SEL-037 Low x 1 Then SEL-110 0.1 mg/kg + SEL-037 Low Dose x 4 Doses | SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg x 1 dose then SEL-110 0.1 mg/kg + Pegadricase 0.2 mg/kg x 4 doses IV every 28 days | 0 | None | 1 | 11 | 9 | 11 | View |
| SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 5 Doses | SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 5 doses | 0 | None | 2 | 12 | 12 | 12 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.1) | View |
| Atrioventricular block | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.1) | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.1) | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.1) | View |
| Acute Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Peripheral oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Acute cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (21.1) | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (21.1) | View |
| Anaphylactic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (21.1) | View |
| Anaphylactic shock | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (21.1) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Soft tissue infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.1) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (21.1) | View |
| Gout flare | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (21.1) | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (21.1) | View |
| Micturition disorder | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (21.1) | View |
| Renal tubular necrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (21.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gout flare | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (21.1) | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (21.1) | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (21.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (21.1) | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (21.1) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.1) | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (21.1) | View |
| Anaphylactic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (21.1) | View |
| Musculoskeletal stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.1) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (21.1) | View |
| Anaphylactic shock | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (21.1) | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.1) | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.1) | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (21.1) | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.1) | View |
| Hyperlipidaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (21.1) | View |
| Micturition urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (21.1) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Paraesthesia oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (21.1) | View |
| Chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | View |
| Hyperfibrinogenaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (21.1) | View |
| Thrombocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (21.1) | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (21.1) | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | View |
| Hypertriglyceridaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (21.1) | View |
| Patellofemoral pain syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | View |
| Chromaturia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (21.1) | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.1) | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.1) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | View |
| Skin laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.1) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (21.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Laryngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Bowel movement irregularity | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Stress | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (21.1) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.1) | View |
| Blood triglycerides increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.1) | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (21.1) | View |
| Muscle strain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.1) | View |
| Tendon injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.1) | View |
| Gingivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (21.1) | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.1) | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Oesophageal oedema | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Formication | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.1) | View |
| Urine odour abnormal | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (21.1) | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (21.1) | View |
| Type 2 diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (21.1) | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.1) | View |
| Infusion site extravasation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (21.1) | View |
| Eye pain | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (21.1) | View |
| Hand dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.1) | View |
| Catheter site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Trichomoniasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Skin abrasion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.1) | View |
| Nocturia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (21.1) | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (21.1) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.1) | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (21.1) | View |
| Vasospasm | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (21.1) | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.1) | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.1) | View |
| myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | View |
| Lip swelling | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.1) | View |
| epicondylitis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.1) | View |
| Rash papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.1) | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | View |
| burning sensation | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.1) | View |
| acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (21.1) | View |
| Pleurisy | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | View |
| Pancreatitis acute | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Cholecystitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (21.1) | View |
| Hepatic enzyme increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.1) | View |
| Swelling of eyelid | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (21.1) | View |
| Dermatitis allergic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.1) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Plantar fasciitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | View |
| Tendonitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | View |
| Metatarsalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | View |
| Oral mucosa haematoma | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Aphthous ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Electrocardiogram QT prolonged | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.1) | View |
| Dental caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Dysphonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (21.1) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.1) | View |
| aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.1) | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.1) | View |
| Phlebitis superficial | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (21.1) | View |
| Varicose vein | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (21.1) | View |
| Tooth abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Electrocardiogram T wave abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.1) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Gingival pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Joint stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | View |
| Joint swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | View |
| Actinic keratosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.1) | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Seborrhoeic keratosis | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.1) | View |
| Prostate infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Prinzmetal angina | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.1) | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.1) | View |
| Hypercholesterolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (21.1) | View |
| Heart rate increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.1) | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Tooth infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Blood pressure diastolic increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.1) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (21.1) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.1) | View |
| Depressed level of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.1) | View |
| Rash pruritic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.1) | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.1) | View |
| Thermal burn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.1) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | View |
| Periodontitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | View |
| Sinus congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | View |
| Diverticulum | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Ovarian cyst | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (21.1) | View |
| Body tinea | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Secretion discharge | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| sinus headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.1) | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | View |
| Parotitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Blood pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.1) | View |
| Ejaculation failure | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (21.1) | View |
| Vitamin D deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (21.1) | View |
| Mouth ulceration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Post-traumatic neck syndrome | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.1) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (21.1) | View |
| Ligament rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.1) | View |
| Rash pustular | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Increased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (21.1) | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.1) | View |
| Arthropod bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.1) | View |
| Groin pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | View |
| Limb discomfort | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | View |
| Nervousness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (21.1) | View |
| Memory impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.1) | View |
| Semen volume decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.1) | View |
| Libido decreased | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (21.1) | View |
| Testicular pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (21.1) | View |
| Feeling hot | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Ecchymosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.1) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (21.1) | View |
| Aphasia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.1) | View |
| Oesophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Pancreatic atrophy | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Hepatomegaly | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (21.1) | View |
| Barrett's oesophagus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Oesophageal stenosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Hot flash | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (21.1) | View |
| Low density lipoprotein increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.1) | View |
| Prostatitis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (21.1) | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Tinea manuum | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (21.1) | View |
| Buried penis syndrome | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (21.1) | View |
| Benign prostatic hyperplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (21.1) | View |
| Joint effusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | View |
| Musculoskeletal Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | View |
| urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.1) | View |
| atrioventricular block second degree | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.1) | View |
| Diabetic neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.1) | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (21.1) | View |
| Night sweats | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.1) | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.1) | View |
| Hand fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.1) | View |
| Ear canal abrasion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.1) | View |
| Dysaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.1) | View |
| Oral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Gastroenteritis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Dermal cyst | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.1) | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.1) | View |
| Hypogeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.1) | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (21.1) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Joint injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.1) | View |