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: 2025-12-25 @ 12:21 AM
Ignite Modification Date: 2025-12-25 @ 10:25 PM
NCT ID: NCT00094458
Description: 1 patient in AZA+PBO group(gp),3 in IFX+PBO gp,1 in IFX+AZA gp were randomized but not treated(Excluded from safety analyses).Safety population for IFX+AZA gp included 11 patients assigned to one of monotherapy gps but inadvertently were given at least one dose of both active oral and intravenous therapy(8 patients in AZA+PBO gp,3 in IFX+PBO gp).
Frequency Threshold: 5
Time Frame: None
Study: NCT00094458
Study Brief: Trial Comparing Infliximab and Infliximab and Azathioprine in the Treatment of Patients With Crohn's Disease na�ve to Both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Chrohn's Disease: SONIC
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
W30-Azathioprine + Placebo Azathioprine (AZA) oral capsules 2.5 mg/kg/day and Placebo (PBO) infusion through Week 30. None None 39 161 120 161 View
W30-Infliximab + Placebo Placebo (PBO) oral daily and Infliximab (IFX) infusions 5 mg/kg through Week 30. None None 26 163 122 163 View
W50-Azathioprine + Placebo (AZA) oral daily 2.5 mg/kg/day and Placebo (PBO) infusion Week 30 through Week 50. None None 5 75 44 75 View
W50-Infliximab + Placebo Placebo (PBO) oral capsules daily and Infliximab (IFX) infusions 5 mg/kg Week 30 through Week 50. None None 15 97 69 97 View
W50-Infliximab + Azathioprine Azathioprine (AZA) oral capsules daily 2.5 mg/kg/day and Infliximab (IFX) infusions 5 mg/kg Week 30 through Week 50. None None 2 108 61 108 View
OLE-Azathioprine + Placebo/Infliximab Azathioprine (AZA) oral capsules daily 2.5mg/kg/day and Placebo (PBO) infusion through Week 50. Infliximab (IFX) infusions 5mg/kg in one year country specific (UE and Israel) Open-Label Extension. None None 1 8 7 8 View
OLE-Infliximab + Placebo/Infliximab Placebo (PBO) oral capsules daily and infliximab (IFX) infusions 5mg/kg through Week 50. Infliximab (IFX) infusions 5mg/kg in one year country specific (UE and Israel) Open-Label Extension. None None 1 18 16 18 View
W30-Infliximab + Azathioprine Azathioprine (AZA) oral daily 2.5 mg/kg/day and Infliximab (IFX) infusions 5mg/kg through Week 30. None None 25 179 133 179 View
OLE-Infliximab + Azathioprine/Infliximab Azathioprine (AZA) oral capsules daily 2.5mg/kg/day and infliximab (IFX) infusions 5mg/kg through Week 50. Infliximab (IFX) infusions 5mg/kg in one year country specific (UE and Israel) Open-Label Extension. None None 3 17 15 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial Infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Papilloedema NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal Pain Upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Anal Fistula NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Colonic Stenosis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Crohn's Disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Duodenal Stenosis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Duodenal Ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Duodenitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Enterocolitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Enterocolonic Fistula NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Faecaloma NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Food Poisoning NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrointestinal Fistula NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Ileal Stenosis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Intestinal Fistula NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Intestinal Obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Intestinal Perforation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Intestinal Stenosis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pancreatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pancreatitis Acute NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Peritonitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Small Intestinal Obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Small Intestinal Stenosis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Subileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Non-Cardiac Chest Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema Peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Hepatitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Hepatitis Acute NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Anaphylactoid Reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Abdominal Abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Abscess Intestinal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Anal Abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Campylobacter Intestinal Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Clostridium Difficile Colitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Erysipelas NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis Viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Herpes Zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Osteomyelitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pelvic Abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Perirectal Abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia Legionella NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pseudomembranous Colitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Psoas Abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Retroperitoneal Abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tooth Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tuberculosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Anastomotic Leak NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Crush Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Hand Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Rib Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Hypovolaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Rotator Cuff Syndrome NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Benign Neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Colon Cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Cerebrovascular Accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Ischaemic Cerebral Infarction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Migraine with Aura NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Paralysis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Abortion Spontaneous NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
Ectopic Pregnancy NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
Conversion Disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Psychotic Disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Nephrolithiasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal Colic NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Urethral Stenosis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Urinary Retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Adenomyosis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Female Genital Tract Fistula NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Ovarian Cyst NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Chronic Obstructive Pulmonary Disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pneumonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyshidrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin Necrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Miscarriage of Partner NON_SYSTEMATIC_ASSESSMENT Social circumstances MedDRA View
Haematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Lymphadenopathy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Angina Pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Ear Pain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Amaurosis Fugax NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eyelids Pruritus NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Ocular Hyperaemia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Panophthalmitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Uveitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Abdominal Discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal Distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal Pain Upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Anal Haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Anal Ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Aphthous Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Crohn's Disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrointestinal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrointestinal Sounds Abnormal NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Intestinal Obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Chest Discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Cyst NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Inflammation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Influenza Like Illness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema Peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Cholelithiasis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Seasonal Allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Ear Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Fungal Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis Viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Herpes Zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Impetigo NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Laryngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Oral Herpes NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tinea Pedis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tooth Abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper Respiratory Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Vulvovaginal Mycotic Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Arthropod Bite NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Epicondylitis NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Face Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Ligament Rupture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Alanine Aminotransferase Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Aspartate Aminotransferase Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood Albumin Abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood Alkaline Phosphatase Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
C-Reactive Protein Abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
C-Reactive Protein Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Hepatic Enzyme Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Liver Function Test Abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Weight Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Lupus-Like Syndrome NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscle Rigidity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal Stiffness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Neck Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Osteopenia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain in Extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Plantar Fasciitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Spondyloarthropathy NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Benign Neoplasm of Skin NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Lethargy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Syncope Vasovagal NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Pregnancy NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Depressed Mood NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Fear NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Sleep Disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Endometriosis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Chronic Obstructive Pulmonary Disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dysphonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Oropharyngeal Pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Productive Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Sinus Disorder NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dry Skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Exfoliative Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Night Sweats NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pain of Skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Photosensitivity Reaction NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pityriasis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Seborrhoeic Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pregnancy of Partner NON_SYSTEMATIC_ASSESSMENT Social circumstances MedDRA View
Tooth Extraction NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Haematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View