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 @ 3:20 AM
Ignite Modification Date: 2025-12-26 @ 1:58 AM
NCT ID: NCT00454805
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00454805
Study Brief: AZD2171 in Addition to Fulvestrant in Patients With Advanced Breast Cancer.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cediranib 45 mg Cediranib 45 mg+Fulvestrant 250 mg Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule: * Day 1: fulvestrant 500 mg im * Day 15: fulvestrant 250 mg im * Day 29, and every 28 days thereafter: fulvestrant 250 mg im * and daily: cediranib 45 mg (administered orally) None None 15 31 29 31 View
Placebo Placebo+Fulvestrant 250 mg Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule: * Day 1: fulvestrant 500 mg im * Day 15: fulvestrant 250 mg im * Day 29, and every 28 days thereafter: fulvestrant 250 mg im * and daily: placebo to match cediranib (administered orally) None None 4 31 30 31 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.1 View
Intracardiac Thrombus SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Small Intestinal Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Multi-Organ Failure SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Weight Decreased SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Water Intoxication SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Pain In Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 11.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Oral Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Gastrooesophageal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Gingival Bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Injection Site Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Non-Cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Weight Decreased SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Weight Increased SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Decreased Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Pain In Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Bone Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Musculoskeletal Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Muscular Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Musculoskeletal Chest Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Peripheral Sensory Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Breast Pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.1 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Oropharyngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Dry Throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
Hyperkeratosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
Palmar-Plantar Erythrodysaesthesia Syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
Skin Hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.1 View
Hot Flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View