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 @ 11:07 PM
Ignite Modification Date: 2025-12-25 @ 8:40 PM
NCT ID: NCT00711269
Description: Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) with a start date on or after the date of the first dose through the end of follow-up, or AEs occurring before the date of first dose and worsening during the treatment or follow-up period. Both TEAEs and treatment-emergent serious AEs are presented for the safety population defined as subjects who receive at least one of the study drug in the treatment phase.
Frequency Threshold: 0
Time Frame: From Baseline to up to 8 weeks
Study: NCT00711269
Study Brief: Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SM-13496 (Lurasidone HCl) 40-mg Group SM-13496 40 mg was administered orally once daily, for 6 weeks. 0 None 8 127 97 127 View
SM-13496 (Lurasidone HCl) 80-mg Group SM-13496 40 mg was administered orally once daily on Days 1 to 7, SM-13496 60 mg on Days 8 to 14, and SM-13496 80 mg on Days 15 to 42. 1 None 7 131 124 131 View
Placebo Group Placebo was administered orally twice daily for 6 weeks. 0 None 10 132 91 132 View
Risperidone Group Risperidone 2 mg was administered orally twice daily on Days 1 to 7, risperidone 3 mg on Days 8 to 14, and risperidone 4 mg on Days 15 to 42. 0 None 2 65 51 65 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Gastric ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Rhabdomyolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Neuroleptic malignant syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Schizophrenia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Psychotic disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Haemorrhoidal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Stomach discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Periodontitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Dermoid cyst SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 11.0 View
Ear haemorrhage SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 11.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 11.0 View
Otorrhoea SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 11.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Asthenopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Oculogyric crisis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Blepharospasm SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Conjunctivitis allergic SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Ocular hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Salivary hypersecretion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Gingivitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Irritability SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Thirst SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Secretion discharge SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Tinea pedis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Excoriation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Blood pressure decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Blood triglycerides increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Protein urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Oral intake reduced SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Polydipsia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Muscle rigidity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Autism SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Dizziness postural SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Drooling SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Parkinsonism SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Tardive dyskinesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Schizophrenia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Psychotic disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Aggression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Depressive symptom SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Abnormal behaviour SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Anal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Chapped lips SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Cheilitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Epigastric discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Faecal incontinence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Lip dry SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Lip ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Tooth loss SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Anal fissure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Breath odour SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Oesophageal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Paraesthesia oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Allergy to arthropod sting SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 11.0 View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 11.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Adenoviral conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Carbuncle SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Eyelid infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Hordeolum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Purulence SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Vaginal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Dermatitis infected SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Furuncle SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Scratch SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Arthropod sting SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Back injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Device breakage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Face injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Mouth injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Nail avulsion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Periorbital haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Foreign body trauma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Urethral injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Blood prolactin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Blood uric acid increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Glucose urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Platelet count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Blood potassium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Deoxypyridinoline urine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Increased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Akathisia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Dyskinesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Dystonia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Parkinsonian gait SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Sedation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Bradykinesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Dissociative disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Amenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.0 View
Dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.0 View
Erectile dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.0 View
Galactorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.0 View
Menstruation delayed SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Tachypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Hyperkeratosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Dermatitis allergic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Dermatitis atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Eczema asteatotic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Haemorrhage subcutaneous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Skin exfoliation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Swelling face SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Cold sweat SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Dermatitis bullous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Ingrowing nail SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Prurigo SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Rash papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Skin discomfort SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View