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 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
NCT ID:
NCT01299727
Description:
None
Frequency Threshold:
5
Time Frame:
From start of study drug administration up to follow-up (Month 103).
Study:
NCT01299727
Study Brief:
Extension of Study HGT-SAN-055 Evaluating Administration of rhHNS in Patients With Sanfilippo Syndrome Type A (MPS IIIA)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| HGT-1410/rhHNS-10 mg | Participants received HGT-1410/Recombinant human heparan N-sulfatase (rhHNS) 10 milligram (mg) for every 4 weeks (Q4W) via an intrathecal drug delivery device (IDDD). | 0 | None | 4 | 4 | 4 | 4 | View |
| HGT-1410/rhHNS-45 mg | Participants received HGT-1410/rhHNS 45 mg for Q4W via IDDD. | 0 | None | 4 | 4 | 4 | 4 | View |
| HGT-1410/rhHNS-90 mg | Participants received HGT-1410/rhHNS 90 mg for Q4W via IDDD. | 0 | None | 3 | 4 | 4 | 4 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Leukocytosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 13.1 | View |
| Auricular pseudocyst | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 13.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Device breakage | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Device component issue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Device failure | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Device leakage | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Device material issue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Central nervous system infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Device related infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Epstein-Barr virus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Implant site infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Lower respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Meningitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Postoperative wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Accidental overdose | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.1 | View |
| Subdural haematoma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.1 | View |
| Wound dehiscence | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.1 | View |
| CSF white blood cell count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.1 | View |
| Intracranial hypotension | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| Medical device change | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 13.1 | View |
| Medical device removal | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 13.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Eosinophilia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 13.1 | View |
| Lymphadenopathy | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 13.1 | View |
| Acquired claw toe | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | View |
| Growing pains | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | View |
| Intervertebral disc protrusion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | View |
| Joint swelling | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | View |
| Mobility decreased | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | View |
| Musculoskeletal stiffness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | View |
| Scoliosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | View |
| Synovial cyst | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | View |
| Toe walking | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | View |
| Weight bearing difficulty | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | View |
| Haematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 13.1 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 13.1 | View |
| Pallor | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 13.1 | View |
| Ear pain | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 13.1 | View |
| Middle ear effusion | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 13.1 | View |
| Otorrhoea | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 13.1 | View |
| Tympanic membrane hyperaemia | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 13.1 | View |
| Tympanic membrane perforation | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 13.1 | View |
| Lacrimation increased | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 13.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Administration site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Varicella | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Procedural vomiting | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.1 | View |
| Haematocrit decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.1 | View |
| Haemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.1 | View |
| Polydipsia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 13.1 | View |
| Akathisia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| Balance disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| Bulbar palsy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| Presyncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| Psychomotor hyperactivity | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| Infection prophylaxis | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 13.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | View |
| Rash macular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.1 | View |
| Rosacea | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.1 | View |
| Scar | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Defaecation urgency | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Eructation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Faeces discoloured | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Mouth ulceration | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Regurgitation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Retching | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Salivary hypersecretion | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Catheter site erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Catheter site haemorrhage | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Catheter site inflammation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Catheter site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Complication of device insertion | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Complication of device removal | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Device breakage | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Device failure | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Device leakage | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Feeling hot | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Gait disturbance | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Implant site effusion | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Implant site swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Irritability | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Local swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Medical device complication | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Thalassaemia trait | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 13.1 | View |
| Mitral valve incompetence | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 13.1 | View |
| Allergy to arthropod bite | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 13.1 | View |
| Hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 13.1 | View |
| Seasonal allergy | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 13.1 | View |
| Abscess oral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Candida nappy rash | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Catheter site infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Central nervous system infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Ear infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Enterobiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Fungal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Helminthic infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Impetigo | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Lower respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Onychomycosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Oral candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Oral herpes | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Otitis externa | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Otitis media | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Otitis media acute | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Post procedural infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Postoperative wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Proteus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Staphylococcal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Tinea pedis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Viral rash | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Viral upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Wound infection staphylococcal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Arthropod bite | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.1 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.1 | View |
| Drug toxicity | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.1 | View |
| Excoriation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.1 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.1 | View |
| Feeding tube complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.1 | View |
| Head injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.1 | View |
| Nail injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.1 | View |
| Open wound | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.1 | View |
| Post procedural discomfort | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.1 | View |
| Procedural headache | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.1 | View |
| Procedural nausea | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.1 | View |
| Procedural pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.1 | View |
| Procedural site reaction | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.1 | View |
| Scratch | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.1 | View |
| Skin laceration | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.1 | View |
| Thermal burn | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.1 | View |
| Blood bicarbonate decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.1 | View |
| Blood creatine phosphokinase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.1 | View |
| Blood uric acid increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.1 | View |
| Body temperature increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.1 | View |
| CSF protein increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.1 | View |
| CSF white blood cell count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.1 | View |
| Lymphocyte count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.1 | View |
| Mean cell haemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.1 | View |
| Mean cell volume decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.1 | View |
| Monocyte count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.1 | View |
| Neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.1 | View |
| Norovirus test positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.1 | View |
| Red blood cells CSF positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.1 | View |
| Serum ferritin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.1 | View |
| Weight decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.1 | View |
| White blood cell count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.1 | View |
| Enuresis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 13.1 | View |
| Incontinence | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 13.1 | View |
| Micturition urgency | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 13.1 | View |
| Urinary incontinence | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 13.1 | View |
| Hyperphagia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 13.1 | View |
| Iron deficiency | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 13.1 | View |
| Cauda equina syndrome | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| Cognitive disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| Crying | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| Drooling | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| Dyskinesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| Head titubation | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| Hyperreflexia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| Hypertonia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| Intracranial hypotension | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| Memory impairment | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| Motor dysfunction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| Nervous system disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| Medical device removal | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 13.1 | View |
| Abnormal behaviour | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 13.1 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 13.1 | View |
| Conversion disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 13.1 | View |
| Depressed mood | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 13.1 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 13.1 | View |
| Intentional self-injury | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 13.1 | View |
| Obsessive-compulsive disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 13.1 | View |
| Restlessness | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 13.1 | View |
| Sleep disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 13.1 | View |
| Stereotypy | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 13.1 | View |
| Dysmenorrhoea | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 13.1 | View |
| Labia enlarged | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 13.1 | View |
| Penile adhesion | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 13.1 | View |
| Penile erythema | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 13.1 | View |
| Uterine haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 13.1 | View |
| Choking | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | View |
| Hyperventilation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | View |
| Nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | View |
| Pharyngeal erythema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | View |
| Dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.1 | View |
| Dermatitis allergic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.1 | View |
| Dermatitis diaper | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.1 | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.1 | View |
| Eczema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.1 | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.1 | View |
| Hyperkeratosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.1 | View |
| Onycholysis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.1 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.1 | View |
| Pruritus generalised | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.1 | View |
| Skin chapped | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.1 | View |
| Activities of daily living impaired | NON_SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA 13.1 | View |
| Trigger finger | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | View |
| Ear canal erythema | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 13.1 | View |
| Tympanic membrane disorder | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 13.1 | View |
| Myopia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 13.1 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Abnormal faeces | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 13.1 | View |