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 @ 10:22 PM
Ignite Modification Date: 2025-12-25 @ 7:55 PM
NCT ID: NCT00383435
Description: Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
Frequency Threshold: 5
Time Frame: None
Study: NCT00383435
Study Brief: Effects of Mometasone Furoate/Formoterol Combination Versus Formoterol and Mometasone Furoate Alone in COPD (Study P04229AM4)(COMPLETED)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MF/F MDI 200/10 MCG BID None None None 13 207 8 207 View
MF/F MDI 400/10 MCG BID None None None 29 217 10 217 View
MF MDI 400 MCG BID None None None 22 210 9 210 View
F MDI 10 MCG BID None None None 29 209 11 209 View
PLACEBO None None None 13 212 11 212 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ACUTE MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
ANGINA PECTORIS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
ANGINA UNSTABLE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
ATRIAL FIBRILLATION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
BRADYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
CARDIAC FAILURE CONGESTIVE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
COR PULMONALE CHRONIC SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
CORONARY ARTERY DISEASE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
PALPITATIONS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
GOITRE SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 13.0 View
CATARACT SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
CATARACT NUCLEAR SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
GLAUCOMA SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
LENTICULAR OPACITIES SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
DIARRHOEA HAEMORRHAGIC SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
EROSIVE OESOPHAGITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
GASTRIC ULCER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
GASTRITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
GASTROINTESTINAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
HERNIAL EVENTRATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
OESOPHAGEAL FOOD IMPACTION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
OESOPHAGEAL RUPTURE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
PEPTIC ULCER PERFORATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
MULTI-ORGAN FAILURE SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
SUDDEN DEATH SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
CHOLECYSTITIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.0 View
CHOLELITHIASIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.0 View
CHRONIC HEPATIC FAILURE SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.0 View
ABSCESS LIMB SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
APPENDICITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
ARTHRITIS BACTERIAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
CELLULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
DIVERTICULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
OESOPHAGEAL CANDIDIASIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
PULMONARY TUBERCULOSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
VIRAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
SKIN LACERATION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
SPINAL COMPRESSION FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
DEHYDRATION SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
ADENOCARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
COLON NEOPLASM SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
EXTRANODAL MARGINAL ZONE B-CELL LYMPHOMA (MALT TYPE) SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
LARYNGEAL CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
LUNG CANCER METASTATIC SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
LUNG NEOPLASM MALIGNANT SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
MALIGNANT PALATE NEOPLASM SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
NON-HODGKIN'S LYMPHOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
CEREBRAL INFARCTION SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
CEREBRAL ISCHAEMIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
CEREBROVASCULAR ACCIDENT SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
CEREBROVASCULAR DISORDER SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
SUBARACHNOID HAEMORRHAGE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
TREMOR SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
VASCULAR HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
RENAL FAILURE ACUTE SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
ACUTE RESPIRATORY FAILURE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
CHRONIC OBSTRUCTIVE PULMONARY DISEASE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
HICCUPS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
HYPOXIA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
PNEUMOMEDIASTINUM SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
PNEUMOTHORAX SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
PULMONARY AMYLOIDOSIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
PULMONARY EMBOLISM SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
RESPIRATORY FAILURE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
CAROTID ENDARTERECTOMY SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 13.0 View
INCISIONAL HERNIA REPAIR SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 13.0 View
FEMORAL ARTERIAL STENOSIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View
PERIPHERAL ARTERY ANEURYSM SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View
POOR PERIPHERAL CIRCULATION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View