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:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
NCT ID:
NCT02343406
Description:
Serious and non-serious adverse events occurring after the subject signed the study-specific informed consent and prior to the initial dose of study drug were to be collected only if they were considered by the Investigator to be causally related to required study procedures.
Frequency Threshold:
5
Time Frame:
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 35 days (adults) or 49 days (pediatric subjects) after the last dose of study drug, up to 125 weeks.
Study:
NCT02343406
Study Brief:
Adult Study: ABT-414 Alone or ABT-414 Plus Temozolomide vs. Lomustine or Temozolomide for Recurrent Glioblastoma Pediatric Study: Evaluation of ABT-414 in Children With High Grade Gliomas
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| ABT-414/Temozolomide | Depatuxizumab mafodotin (ABT-414) administered once every 2 weeks in combination with temozolomide (TMZ) to adult subjects | 80 | None | 39 | 88 | 84 | 88 | View |
| ABT-414_adult | Depatuxizumab mafodotin (ABT-414) administered once every 2 weeks to adult subjects | 80 | None | 30 | 84 | 76 | 84 | View |
| Control_lomustine | Adult subjects relapsing during temozolomide (TMZ) treatment or within the first 16 weeks after the first day of the last TMZ cycle received lomustine on Day 1 of every 42-day treatment period until one of the treatment withdrawal criteria was met, up to a maximum of 1 year. | 52 | None | 19 | 56 | 46 | 56 | View |
| Control_ Temozolomide | Adult subjects relapsing 16 weeks or more after the first day of the last temozolomide (TMZ) cycle received TMZ on Day 1 to Day 5 for the first 28-day cycle, with dose escalation in subsequent cycles in case of adequate tolerance and treatment continuing until one of the treatment withdrawal criteria was met. | 21 | None | 5 | 21 | 20 | 21 | View |
| ABT-414_ Pediatric | Depatuxizumab mafodotin (ABT-414) administered once every 2 weeks to pediatric participants. Temozolomide (TMZ) was only allowed for pediatric participants if its use was in accordance with local clinical practice, and was not considered an investigational product for the study (unless this was a local requirement). | 5 | None | 3 | 6 | 6 | 6 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| FEBRILE NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 22.0 | View |
| THROMBOCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 22.0 | View |
| VERTIGO | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 22.0 | View |
| CORNEAL EPITHELIAL MICROCYSTS | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| DIVERTICULAR PERFORATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| DISEASE PROGRESSION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| GENERAL PHYSICAL HEALTH DETERIORATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| HEPATIC STEATOSIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 22.0 | View |
| DIVERTICULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| LOWER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| MENINGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| RESPIRATORY TRACT INFECTION VIRAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| WOUND INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| CLAVICLE FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.0 | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.0 | View |
| FEMORAL NECK FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.0 | View |
| HIP FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.0 | View |
| HUMERUS FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.0 | View |
| LUMBAR VERTEBRAL FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.0 | View |
| PELVIC FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.0 | View |
| ALANINE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.0 | View |
| BODY TEMPERATURE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.0 | View |
| DECREASED APPETITE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.0 | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.0 | View |
| HYPERGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.0 | View |
| HYPONATRAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.0 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | View |
| MUSCULAR WEAKNESS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | View |
| MALIGNANT NEOPLASM PROGRESSION | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | View |
| METASTASES TO PERITONEUM | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | View |
| NEOPLASM PROGRESSION | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | View |
| TUMOUR HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | View |
| APHASIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| APRAXIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| BRAIN OEDEMA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| CEREBROVASCULAR ACCIDENT | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| EPILEPSY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| GENERALISED TONIC-CLONIC SEIZURE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| HAEMORRHAGE INTRACRANIAL | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| HEMIPARESIS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| HEMIPLEGIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| HYDROCEPHALUS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| MUSCLE SPASTICITY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| NERVOUS SYSTEM DISORDER | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| NEUROLOGICAL DECOMPENSATION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| PARTIAL SEIZURES | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| SEIZURE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| STATUS EPILEPTICUS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| SUBDURAL HYGROMA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| SYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| TRANSIENT ISCHAEMIC ATTACK | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| COMPLETED SUICIDE | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.0 | View |
| CONFUSIONAL STATE | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.0 | View |
| SUICIDAL IDEATION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.0 | View |
| SUICIDE ATTEMPT | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.0 | View |
| NEPHROLITHIASIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 22.0 | View |
| HYPOXIA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | View |
| PNEUMONIA ASPIRATION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | View |
| PNEUMONITIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | View |
| PULMONARY EMBOLISM | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | View |
| RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | View |
| DEEP VEIN THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 22.0 | View |
| SUBGALEAL HAEMATOMA | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 22.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 22.0 | View |
| LEUKOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 22.0 | View |
| LYMPHOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 22.0 | View |
| NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 22.0 | View |
| THROMBOCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 22.0 | View |
| BRADYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 22.0 | View |
| SINUS BRADYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 22.0 | View |
| EAR PAIN | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 22.0 | View |
| CUSHINGOID | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 22.0 | View |
| CATARACT | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| CORNEAL EPITHELIAL MICROCYSTS | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| CORNEAL OPACITY | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| DRY EYE | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| EYE IRRITATION | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| EYE PAIN | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| EYELID PTOSIS | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| KERATITIS | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| KERATOPATHY | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| LACRIMATION INCREASED | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| OCULAR DISCOMFORT | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| PHOTOPHOBIA | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| PUNCTATE KERATITIS | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| PUPILLARY REFLEX IMPAIRED | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| VISION BLURRED | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| VISUAL IMPAIRMENT | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| ABDOMINAL DISTENSION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| PROCTALGIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| GAIT DISTURBANCE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| INFLUENZA LIKE ILLNESS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| OEDEMA PERIPHERAL | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| CONJUNCTIVITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| EYE INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| INFLUENZA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| ORAL CANDIDIASIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| VAGINAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| VULVOVAGINAL CANDIDIASIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.0 | View |
| ALANINE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.0 | View |
| ASPARTATE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.0 | View |
| BLOOD CULTURE POSITIVE | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.0 | View |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.0 | View |
| LYMPHOCYTE COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.0 | View |
| NEUTROPHIL COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.0 | View |
| PLATELET COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.0 | View |
| WEIGHT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.0 | View |
| WEIGHT INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.0 | View |
| WHITE BLOOD CELL COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.0 | View |
| DECREASED APPETITE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.0 | View |
| HYPERGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.0 | View |
| HYPERKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.0 | View |
| HYPERMAGNESAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.0 | View |
| HYPOKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.0 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | View |
| MUSCLE SPASMS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | View |
| MUSCULAR WEAKNESS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | View |
| MUSCULOSKELETAL PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | View |
| PAIN IN JAW | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | View |
| APHASIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| ATAXIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| BALANCE DISORDER | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| DEPRESSED LEVEL OF CONSCIOUSNESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| DYSARTHRIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| ENCEPHALOPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| HEMIPARESIS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| HYDROCEPHALUS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| PERIPHERAL MOTOR NEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| SEIZURE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| SOMNOLENCE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.0 | View |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.0 | View |
| DISINHIBITION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.0 | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.0 | View |
| URINARY INCONTINENCE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 22.0 | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | View |
| DYSPHONIA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | View |
| EPISTAXIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | View |
| NASAL CONGESTION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | View |
| OROPHARYNGEAL PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | View |
| PRODUCTIVE COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | View |
| DERMATITIS DIAPER | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.0 | View |
| DRY SKIN | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.0 | View |
| ERYTHEMA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.0 | View |
| HYPERKERATOSIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.0 | View |
| PRURITUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.0 | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.0 | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 22.0 | View |
| HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 22.0 | View |