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 @ 7:42 PM
Ignite Modification Date: 2025-12-25 @ 5:21 PM
NCT ID: NCT00038103
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00038103
Study Brief: Open-Label Study Of Exemestane With Or Without Celecoxib In Postmenopausal Women With ABC Having Progressed On Tamoxifen
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Combination (Exemestane + Celecoxib) oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily) None None 14 None 43 None View
Exemestane (Exemestane Alone) oral dose exemestane taken with food (25 mg tablet once daily) None None 9 None 45 None View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Jaundice SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Post procedural complication SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Death SYSTEMATIC_ASSESSMENT General disorders None View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders None View
Asterixis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Gait Disturbance SYSTEMATIC_ASSESSMENT General disorders None View
Disorientation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Asthenia SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Lung Disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Intestinal Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Knee Arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Scleroderma SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Miller Fisher Syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Polyneuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Paresis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Back Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Metastatic Neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Dermatitis Allergic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Cardiac Failure Congestive SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Wrist Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Breast Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (v5.1) View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cheilitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Faecal incontinence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Tinea pedis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tracheitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Wrist fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Alanine aminotransferase SYSTEMATIC_ASSESSMENT Investigations None View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations None View
Pulse pressure increased SYSTEMATIC_ASSESSMENT Investigations None View
Hypoproteinaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Osteitis deformans SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Rheumatoid arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Scleroderma SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Metastatic neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Brachial plexopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Carpal tunnel syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Miller Fisher syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paresis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Polyneuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Urge incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis allergic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Cholecystectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Knee arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Varicose vein SYSTEMATIC_ASSESSMENT Vascular disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Odynophagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Peptic ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Asthenia SYSTEMATIC_ASSESSMENT General disorders None View
Axillary pain SYSTEMATIC_ASSESSMENT General disorders None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Death SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders None View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders None View
Inflammation SYSTEMATIC_ASSESSMENT General disorders None View
Oedema SYSTEMATIC_ASSESSMENT General disorders None View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Ulcer haemorrhage SYSTEMATIC_ASSESSMENT General disorders None View
Jaundice SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders None View
Fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lymphangitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Joint dislocation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Medical device complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Post procedural complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase SYSTEMATIC_ASSESSMENT Investigations None View
Blood alkaline phosphatase SYSTEMATIC_ASSESSMENT Investigations None View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Gamma-glutamyltransferase SYSTEMATIC_ASSESSMENT Investigations None View
Low density lipoprotein SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations None View
Weight increased SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Joint stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Tumour pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Asterixis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peroneal nerve palsy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sensory loss SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Disorientation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pyuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Breast pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vaginal discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vaginal haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vulvovaginal pruritus SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Lung disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Lymphoedema SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pallor SYSTEMATIC_ASSESSMENT Vascular disorders None View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Vasodilatation SYSTEMATIC_ASSESSMENT Vascular disorders None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Visual impairment SYSTEMATIC_ASSESSMENT Eye disorders None View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mouth ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Acarodermatitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Breast cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchitis viral SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View