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 @ 11:21 PM
Ignite Modification Date:
2025-12-25 @ 9:03 PM
NCT ID:
NCT01515956
Description:
None
Frequency Threshold:
5
Time Frame:
52 weeks
Study:
NCT01515956
Study Brief:
Study of BMN 110 in Pediatric Patients < 5 Years of Age With Mucopolysaccharidosis IVA (Morquio A Syndrome)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| BMN110 2.0 mg/kg/Week | BMN110 2.0 mg/kg/week | None | None | 8 | 15 | 15 | 15 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Developmental hip dysplasia | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 16.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Medical device complication | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 16.1 | View |
| Device related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Joint instability | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Knee deformity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Cerebrospinal fluid leakage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Cervical cord compression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Spinal cord oedema | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Tonsillar hypertrophy | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Poor venous access | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.1 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.1 | View |
| Developmental hip dysplasia | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 16.1 | View |
| Aural polyp | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 16.1 | View |
| Cerumen impaction | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 16.1 | View |
| Conductive deafness | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 16.1 | View |
| Deafness | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 16.1 | View |
| Deafness bilateral | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 16.1 | View |
| Ear haemorrhage | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 16.1 | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 16.1 | View |
| Hearing impaired | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 16.1 | View |
| Middle ear effusion | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 16.1 | View |
| Motion sickness | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 16.1 | View |
| Otorrhoea | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 16.1 | View |
| Amblyopia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.1 | View |
| Astigmatism | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.1 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.1 | View |
| Conjunctivitis allergic | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.1 | View |
| Corneal opacity | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.1 | View |
| Eye discharge | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.1 | View |
| Eye pain | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.1 | View |
| Eye swelling | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.1 | View |
| Keratitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.1 | View |
| Trichiasis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.1 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Dental caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Gingival pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Mouth ulceration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Oral discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Oral disorder | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Retching | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Catheter site extravasation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Catheter site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Catheter site related reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Crepitations | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Device difficult to use | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Gait disturbance | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Implant site haemorrhage | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Infusion site extravasation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Injection site hypersensitivity | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Local swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Mass | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Medical device complication | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Medical device pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Medical device site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Hepatic function abnormal | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 16.1 | View |
| Portal vein thrombosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 16.1 | View |
| Acute sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Acute tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Anal fungal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Conjunctivitis infective | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Diarrhoea infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Ear infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Exanthema subitum | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Fungal skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Gastroenteritis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Gingival infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Hand-foot-and-mouth disease | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Herpes simplex | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Hordeolum | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Implant site infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Molluscum contagiosum | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Otitis externa | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Otitis media acute | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Otitis media chronic | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Penile infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Postoperative wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Rash pustular | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Tooth infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Viral rash | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Eye contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Foot fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Injury corneal | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Limb crushing injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Lip injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Postoperative fever | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Procedural pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Procedural vomiting | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Scar | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Spinal cord injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Thermal burn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Blood bicarbonate decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Body temperature increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Breath sounds abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Heart rate increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Oxygen saturation decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Respiratory rate increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Venous pressure decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Joint swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Limb discomfort | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Musculoskeletal stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Spinal disorder | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Cerebral haematoma | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 16.1 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.1 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.1 | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.1 | View |
| Vesicoureteric reflux | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.1 | View |
| Balanoposthitis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 16.1 | View |
| Oedema genital | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 16.1 | View |
| Adenoidal hypertrophy | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Allergic respiratory disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Increased upper airway secretion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Laryngospasm | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Nasal obstruction | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Sleep apnoea syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Sneezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Throat irritation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Tonsillar hypertrophy | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Blister | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Cold sweat | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Dermatitis allergic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Dermatitis diaper | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Petechiae | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Rash erythematous | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Rash papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Skin disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Skin reaction | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Catheter placement | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.1 | View |
| Central venous catheter removal | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.1 | View |
| Central venous catheterisation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.1 | View |
| Dental care | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.1 | View |
| Ear tube insertion | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.1 | View |
| Ear tube removal | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.1 | View |
| Infusion | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.1 | View |
| Joint fluid drainage | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.1 | View |
| Orchidopexy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.1 | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.1 | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.1 | View |
| Hyperaemia | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.1 | View |
| Pallor | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.1 | View |
| Poor venous access | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.1 | View |