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 @ 1:41 PM
Ignite Modification Date: 2025-12-25 @ 12:37 PM
NCT ID: NCT01704495
Description: None
Frequency Threshold: 1
Time Frame: 12 months
Study: NCT01704495
Study Brief: A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of AZD5069 in Patients With Uncontrolled Persistent Asthma.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AZD5069 45 mg BID AZD5069 oral capsules self-administered twice daily None None 14 161 86 161 View
AZD5069 15 mg BID AZD5069 oral capsules self-administered twice daily None None 8 153 68 153 View
AZD5069 5 mg BID AZD5069 oral capsules self-administered twice daily None None 7 156 74 156 View
Placebo Placebo oral capsules self-administered twice daily None None 13 159 96 159 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
PATELLA FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations None View
RENAL CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
LUNG NEOPLASM MALIGNANT SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
UTERINE LEIOMYOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
ABDOMINAL ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations None View
HELICOBACTER GASTRITIS SYSTEMATIC_ASSESSMENT Infections and infestations None View
LOWER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
LOWER RESPIRATORY TRACT INFECTION BACTERIAL SYSTEMATIC_ASSESSMENT Infections and infestations None View
SALMONELLOSIS SYSTEMATIC_ASSESSMENT Infections and infestations None View
STREPTOCOCCAL SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations None View
VIRAL UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
ACUTE TONSILLITIS SYSTEMATIC_ASSESSMENT Infections and infestations None View
NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
CRITICAL ILLNESS POLYNEUROPATHY SYSTEMATIC_ASSESSMENT Nervous system disorders None View
ISCHAEMIC STROKE SYSTEMATIC_ASSESSMENT Nervous system disorders None View
ATRIAL FIBRILLATION SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CORONARY ARTERY DISEASE SYSTEMATIC_ASSESSMENT Cardiac disorders None View
PERIPHERAL EMBOLISM SYSTEMATIC_ASSESSMENT Vascular disorders None View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders None View
ASTHMA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
ASTHMATIC CRISIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
BARRETTS OESOPHAGUS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
GASTRITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
HIATUS HERNIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ABDOMINAL HERNIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
INGUINAL HERNIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
CHOLECYSTITIS CHRONIC SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
CHOLELITHIASIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
CALCULUS URETERIC SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
OVARIAN CYST SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
PSEUDOHYPOPARATHYROIDISM SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
ALANINE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations None View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
GASTROOESOPHAGEAL REFLUX DISEASE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders None View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations None View
PHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations None View
VIRAL UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
INFLUENZA SYSTEMATIC_ASSESSMENT Infections and infestations None View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations None View
RHINITIS SYSTEMATIC_ASSESSMENT Infections and infestations None View
SINUSITIS SYSTEMATIC_ASSESSMENT Infections and infestations None View
LOWER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
GASTROENTERITIS SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
ASTHMA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View