Adverse Events Module

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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 @ 1:15 PM
Ignite Modification Date: 2025-12-25 @ 12:24 PM
NCT ID: NCT00404495
Description: The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Frequency Threshold: 0
Time Frame: None
Study: NCT00404495
Study Brief: Combination of Irinotecan and Temozolomide in Children With Brain Tumors.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Temozolomide + Irinotecan for Medulloblastoma For participants with medulloblastoma: Irinotecan 10 mg/m\^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m\^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression. None None 31 66 64 66 View
Temozolomide + Irinotecan for High-Grade Glioma For participants with high-grade glioma: Irinotecan 10 mg/m\^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m\^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy. None None 5 17 17 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Pancytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Proctalgia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Disease progression 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
Drug hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 13.1 View
Febrile infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Herpes zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Staphylococcal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Shunt occlusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Blood culture positive NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Medulloblastoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Coma NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Complex partial seizures NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Epilepsy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Hydrocephalus NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Hypotonia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Intracranial pressure increased NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Respiratory disorder NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Angiopathy NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Eosinopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Leukopenia 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
Lymphopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Sinus tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Aplasia NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 13.1 View
Deafness NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 13.1 View
Ear canal erythema NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 13.1 View
Ear pain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 13.1 View
Hypoacusis NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 13.1 View
Tinnitus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 13.1 View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 13.1 View
Conjunctival hyperaemia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Diplopia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Eye movement disorder NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Eye pain NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Eyelid ptosis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Keratitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Lacrimation increased NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Strabismus NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Visual acuity reduced NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Anal erosion NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Anal fissure NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Anal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Aphthous stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Breath odour NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Faecal incontinence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Gastrointestinal ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Gingival bleeding NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Lip oedema 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
Odynophagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Oral mucosal eruption NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Oral pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Proctalgia 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
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Adverse drug reaction NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Catheter site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Catheter site rash NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Catheter site swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Device occlusion NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Feeling abnormal 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
General physical health deterioration NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Mucosal inflammation 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
Xerosis NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Drug hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 13.1 View
Acute sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Device related infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Ear infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Herpes zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Hordeolum NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Localised infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Nasopharyngitis 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
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Tonsillitis 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
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Viral rhinitis 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
Animal 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
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
Head injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Joint sprain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Post procedural discharge 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
Wound NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Alanine aminotransferase NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Aspartate aminotransferase NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Blood bicarbonate decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Blood bicarbonate increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Blood culture positive NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Blood magnesium decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Blood phosphorus decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Blood potassium decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Blood urea decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
C-reactive protein increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Haemoglobin NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Haemoglobin decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Heart rate 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
Platelet count NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Protein total increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hyperalbuminaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hypermagnesaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hypocalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hypochloraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hypomagnesaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hypophagia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hypophosphataemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Malnutrition NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Arthropathy 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
Bone pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Joint range of motion decreased 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
Limb discomfort NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Muscular weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Musculoskeletal chest pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Musculoskeletal pain 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
Neck pain 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
Pain in jaw NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Melanocytic naevus NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Skin papilloma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Tumour associated fever NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Aphasia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Ataxia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Balance disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Cerebellar syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Cholinergic syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Cranial nerve disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Cranial nerve paralysis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Dysarthria NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Hydrocephalus NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Hyperreflexia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
IIIrd nerve paralysis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Intracranial pressure increased NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Lethargy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Meningeal disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Monoparesis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Muscle spasticity NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Neuralgia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Neurological symptom NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Neuropathy peripheral NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Nystagmus NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Partial seizures NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Peripheral motor neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Presyncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Pyramidal tract syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Reflexes abnormal NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Sensory disturbance NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Speech disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Tardive dyskinesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Tonic convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Visual field defect NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Confusional state NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Disorientation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Nightmare NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Pollakiuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Urinary incontinence NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Urine flow decreased NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Urogenital haemorrhage NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Genital lesion NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.1 View
Penis disorder NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.1 View
Vulvovaginal discomfort NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.1 View
Bronchospasm NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Dyspnoea 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
Hiccups NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Hypoxia 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
Respiratory disorder NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Rhinalgia 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
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Decubitus ulcer NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Dermatitis 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
Ecchymosis 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
Hyperhidrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Ingrowing nail NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Nail disorder NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Petechiae 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
Rash macular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Rash pruritic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Skin fissures NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Skin hyperpigmentation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Skin striae NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Flushing NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Haematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Hot flush NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Orthostatic hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Pallor NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View