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 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
NCT ID:
NCT02055118
Description:
For IT Treatment group 34 participants were randomized but only 33 participants are part of the safety population as 1 participant discontinued the study without receiving study treatment.
Frequency Threshold:
5
Time Frame:
From start of study treatment up to Week 53
Study:
NCT02055118
Study Brief:
Study of Intrathecal Idursulfase-IT Administered in Conjunction With Elaprase® in Pediatric Patients With Hunter Syndrome and Early Cognitive Impairment
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| No IT Treatment | Participants aged 3 to \< 18 years received Elaprase therapy as standard of care for 12 months. | 0 | None | 2 | 15 | 14 | 15 | View |
| IT Treatment | Participants aged 3 to \< 18 years received IT injections of 10 mg Idursulfase-IT once monthly for 12 months through SOPH-A-PORT Mini S IDDD along with Elaprase. | 0 | None | 12 | 33 | 33 | 33 | View |
| Substudy | Participants aged less than 3 years received Idursulfase-IT monthly once for 12 months along with Elaprase at a dose of 5 mg if aged \<= 8 months; 7.5 mg if aged \> 8 to 30 months and 10 mg if aged \> 30 months to 3 years. | 0 | None | 7 | 9 | 9 | 9 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Respiratory syncytial virus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Device dislocation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Device failure | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Device kink | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Hyperthermia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Hypothermia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Catheter site cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Device related infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Implant site infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.1 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Implant site effusion | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Inflammation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Vascular complication associated with device | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Meningitis bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Stenotrophomonas infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Procedural nausea | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Procedural pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Procedural vomiting | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Pseudomeningocele | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Wound dehiscence | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| CSF cell count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Cerebrospinal fluid leakage | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypochromasia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.1 | View |
| Leukocytosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Foot deformity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Joint range of motion decreased | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Joint stiffness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Knee deformity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Kyphosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Muscle tightness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Spinal disorder | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Spondylolysis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Toe walking | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Trigger finger | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Diastolic hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.1 | View |
| Diastolic hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.1 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.1 | View |
| Systolic hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.1 | View |
| Motion sickness | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 16.1 | View |
| Otorrhoea | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 16.1 | View |
| Astigmatism | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.1 | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.1 | View |
| Excessive eye blinking | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.1 | View |
| Abdominal distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Dental caries | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Frequent bowel movements | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Perianal erythema | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Swollen tongue | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Teething | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Catheter site oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Catheter site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Catheter site swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Device breakage | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Device component issue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Device dislocation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Device kink | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Device occlusion | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Gait disturbance | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Hyperthermia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Implant site effusion | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Implant site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Implant site swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Irritability | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Medical device complication | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Medical device pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Puncture site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Vascular complication associated with device | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Congenital osteodystrophy | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 16.1 | View |
| Dilatation ventricular | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.1 | View |
| Sinus bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.1 | View |
| Sinus tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.1 | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.1 | View |
| Allergy to animal | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 16.1 | View |
| Drug hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 16.1 | View |
| Adenovirus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Atypical pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Ear infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Ear infection fungal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Fungal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Gastroenteritis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Gastrointestinal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Hand-Foot-And-Mouth disease | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Localised infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Lower respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Metapneumovirus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Nail infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Otitis media | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Otitis media acute | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Periodontitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Pharyngitis streptococcal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Tinea infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Tinea pedis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Viral pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Viral rash | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Viral upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Arthropod bite | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Excoriation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Head injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Incision site erythema | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Incision site oedema | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Incision site pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Infusion related reaction | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Laceration | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Procedural headache | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Procedural hypertension | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Procedural hypotension | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Procedural nausea | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Procedural pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Procedural vomiting | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Pseudomeningocele | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Scar | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Thermal burn | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Wound secretion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Albumin CSF increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Bacterial test positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Blood alkaline phosphatase decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Blood calcium decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Blood pressure diastolic decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Blood pressure diastolic increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Blood pressure increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Blood pressure systolic decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Blood pressure systolic increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Blood thyroid stimulating hormone increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Blood triglycerides increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Body temperature decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Body temperature increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| CSF cell count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| CSF glucose decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| CSF mononuclear cell count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| CSF pressure increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| CSF protein increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| CSF white blood cell count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Cardiac murmur | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Coagulation time prolonged | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Electrocardiogram QT prolonged | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Eosinophil count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Eosinophil percentage increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Gamma-Glutamyltransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Haematocrit decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Haemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Heart rate decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Heart rate increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Lymphocyte count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Mean cell volume decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Monocyte count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Neutrophil count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Nuclear magnetic resonance imaging abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Nuclear magnetic resonance imaging brain abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Oxygen saturation decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Protein total decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Red blood cell count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Red blood cells CSF positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Respiratory rate decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Respiratory rate increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Urine leukocyte esterase positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| White blood cell count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| White blood cell count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| White blood cells urine positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| X-Ray abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Polyuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.1 | View |
| Proteinuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.1 | View |
| Hepatomegaly | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 16.1 | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.1 | View |
| Iron deficiency | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.1 | View |
| Carpal tunnel syndrome | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Cerebrospinal fluid leakage | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Drooling | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Intracranial pressure increased | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Lethargy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Psychomotor hyperactivity | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Subdural effusion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Abnormal behaviour | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 16.1 | View |
| Affect lability | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 16.1 | View |
| Aggression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 16.1 | View |
| Agitation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 16.1 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 16.1 | View |
| Communication disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 16.1 | View |
| Dysphemia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 16.1 | View |
| Impulsive behaviour | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 16.1 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 16.1 | View |
| Self injurious behaviour | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 16.1 | View |
| Sleep disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 16.1 | View |
| Social avoidant behaviour | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 16.1 | View |
| Atelectasis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Hiccups | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Interstitial lung disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Pulmonary congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Wheezing | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Blister | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Dermatitis allergic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Dermatitis contact | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Dermatitis diaper | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Generalised erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Rash erythematous | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Rash generalised | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Rash maculo-papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Rash papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Red man syndrome | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Scab | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Skin irritation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |