Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 11:51 PM
Ignite Modification Date: 2025-12-25 @ 9:46 PM
NCT ID: NCT01300351
Description: None
Frequency Threshold: 0
Time Frame: Adverse Events will be collected from time of signature of informed consent throughout the treatment period and up to 8 weeks after the last injection of study medication.
Study: NCT01300351
Study Brief: Comparing the Efficacy and Tolerability of Fulvestrant 500 mg Versus 250 mg in Advanced Breast Cancer Women
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fulvestrant 500 mg Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only None None 4 109 68 109 View
Fulvestrant 250 mg Fulvestrant 250 mg im every 28 (± 3) days None None 9 110 65 110 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Haemolytic uraemic syndrome NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Cardiac failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Hepatic function abnormal NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Arthritis bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lung infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Haemoglobin decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Bone pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Cerebral infarction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
COUGH NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
ANAEMIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
BONE MARROW FAILURE NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
LEUKOPENIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
THROMBOCYTOPENIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
FEBRILE NEUTROPENIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
HAEMOLYTIC URAEMIC SYNDROME NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
LYMPHADENITIS NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
NEUTROPENIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
ACUTE CORONARY SYNDROME NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
CARDIAC FAILURE NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
SINUS TACHYCARDIA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
SUPRAVENTRICULAR EXTRASYSTOLES NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
DEAFNESS UNILATERAL NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
EAR PAIN NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
TINNITUS NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
VERTIGO NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
EYELID OEDEMA NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
DIARRHOEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ABDOMINAL PAIN NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
CONSTIPATION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ABDOMINAL DISCOMFORT NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ABDOMINAL PAIN LOWER NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ABDOMINAL PAIN UPPER NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ASCITES NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
FAECES HARD NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
GASTRITIS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
GINGIVAL PAIN NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
HAEMATOCHEZIA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
MOUTH ULCERATION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
TOOTHACHE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
HEPATIC FUNCTION ABNORMAL NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
PYREXIA NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
MALAISE NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
OEDEMA PERIPHERAL NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
INJECTION SITE PRURITUS NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
ASTHENIA NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
INJECTION SITE ANAESTHESIA NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
INJECTION SITE MASS NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
LOCAL SWELLING NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
FACE OEDEMA NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
INJECTION SITE INDURATION NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
INJECTION SITE JOINT PAIN NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
INJECTION SITE RASH NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
INJECTION SITE SWELLING NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
OEDEMA NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
PAIN NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
UPPER RESPIRATORY TRACT INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
LUNG INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
URINARY TRACT INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
ARTHRITIS BACTERIAL NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
BRONCHOPNEUMONIA 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
LIP INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
PHARYNGITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
URETHRITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
VIRAL RHINITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
VULVITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
FOREARM FRACTURE NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
INJECTION RELATED REACTION NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
LIGAMENT SPRAIN NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
NEUTROPHIL COUNT DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
WHITE BLOOD CELL COUNT DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
ALANINE AMINOTRANSFERASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
ASPARTATE AMINOTRANSFERASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
PLATELET COUNT DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
WEIGHT DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
BLOOD ALKALINE PHOSPHATASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
BLOOD CREATININE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
BLOOD FIBRINOGEN DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
ELECTROCARDIOGRAM ABNORMAL NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
HAEMOGLOBIN DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
HYPERGLYCAEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
HYPOGLYCAEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
HYPERCALCAEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
HYPERURICAEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
ARTHRALGIA NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
MUSCULOSKELETAL PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
MYALGIA NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
PAIN IN EXTREMITY NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
FLANK PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
MUSCULOSKELETAL CHEST PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
NECK PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
ARTHRITIS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
ARTHROPATHY NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
JOINT SWELLING NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
MUSCULAR WEAKNESS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
BONE PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
EPILEPSY NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
FACIAL NERVE DISORDER NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
HAEMORRHAGE INTRACRANIAL NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
HYPERSOMNIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
HYPOAESTHESIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
INSOMNIA NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
MENOPAUSAL DEPRESSION NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
RESTLESSNESS NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
BREAST SWELLING NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
MENOPAUSAL SYMPTOMS NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
PRODUCTIVE COUGH NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
DYSPNOEA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
DYSPHONIA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
EPISTAXIS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
LARYNGEAL PAIN NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
NIGHT SWEATS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
PRURITUS GENERALISED NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
RASH NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
RASH ERYTHEMATOUS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
RASH MACULO-PAPULAR NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
RASH PRURITIC NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
SKIN MASS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
URTICARIA NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
HYPERTENSION NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
HOT FLUSH NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
DIZZINESS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
CEREBRAL INFARCTION NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
OROPHARYNGEAL PAIN NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
PRURITUS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
DERMATITIS ALLERGIC NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
INJECTION SITE REACTION NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
INJECTION SITE PAIN NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
FATIGUE NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
NAUSEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
BACK PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
PALPITATIONS NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
VOMITING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
NASOPHARYNGITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
HEPATIC ENZYME INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
WHITE BLOOD CELL COUNT INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
DECREASED APPETITE NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
HEADACHE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View