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 @ 7:36 PM
Ignite Modification Date: 2025-12-25 @ 5:17 PM
NCT ID: NCT00545103
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00545103
Study Brief: Prevention of Recurrence of Diverticulitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SPD476 (2.4 g) 2.4 g administered orally once daily None None 13 147 111 147 View
SPD476 (4.8 g) 4.8 g administered orally once daily None None 14 149 110 149 View
SPD476 (1.2 g) 1.2 g administered orally once daily None None 9 148 108 148 View
Placebo Placebo administered orally once daily None None 15 142 105 142 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Agranulocytosis None Blood and lymphatic system disorders None View
Angina pectoris None Cardiac disorders None View
Atrial fibrillation None Cardiac disorders None View
Cardiac failure None Cardiac disorders None View
Ventricular extrasystoles None Cardiac disorders None View
Supraventricular tachycardia None Cardiac disorders None View
Gastroesophogeal reflux disease None Gastrointestinal disorders None View
Small intestinal hemorrhage None Gastrointestinal disorders None View
Abdominal pain None Gastrointestinal disorders None View
Gastrointestinal hemorrhage None Gastrointestinal disorders None View
Hiatus hernia None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Esophagitis None Gastrointestinal disorders None View
Abdominal pain lower None Gastrointestinal disorders None View
Abdominal pain upper None Gastrointestinal disorders None View
Dyspepsia None Gastrointestinal disorders None View
Mallory-Weiss syndrome None Gastrointestinal disorders None View
Chest pain None General disorders None View
Multi-organ failure/Death None General disorders None View
Chest discomfort None General disorders None View
Cholangitis acute None Hepatobiliary disorders None View
Cholecystitis None Hepatobiliary disorders None View
Pneumonia None Infections and infestations None View
Subcutaneous abscess None Infections and infestations None View
Appendicitis None Infections and infestations None View
Bronchitis None Infections and infestations None View
Peridiverticular abscess None Infections and infestations None View
Pharyngitis None Infections and infestations None View
Borrelia infection None Infections and infestations None View
Pneumonia viral None Infections and infestations None View
Viral pericarditis None Infections and infestations None View
Humerus fracture None Injury, poisoning and procedural complications None View
Ankle fracture None Injury, poisoning and procedural complications None View
Patella fracture None Injury, poisoning and procedural complications None View
Post procedural edema None Injury, poisoning and procedural complications None View
Radius fracture None Injury, poisoning and procedural complications None View
Hip fracture None Injury, poisoning and procedural complications None View
Type 2 diabetes mellitus None Metabolism and nutrition disorders None View
Intervertebral disc protrusion None Musculoskeletal and connective tissue disorders None View
Arthritis None Musculoskeletal and connective tissue disorders None View
Rotator cuff syndrome None Musculoskeletal and connective tissue disorders None View
Spinal column stenosis None Musculoskeletal and connective tissue disorders None View
Ovarian granulosa-theca cell tumor None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Renal cell carcinoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Squamous cell carcinoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Breast cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cardiac neoplasm unspecified None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Prostate cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Malignant melanoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cerebrovascular accident None Nervous system disorders None View
Syncope None Nervous system disorders None View
Transient ischemic attack None Nervous system disorders None View
Panic attack None Psychiatric disorders None View
Ovarian cyst None Reproductive system and breast disorders None View
Uterovaginal prolapse None Reproductive system and breast disorders None View
Dyspnea None Respiratory, thoracic and mediastinal disorders None View
Hypotension None Vascular disorders None View
Intra-abdominal hemorrhage None Vascular disorders None View
Femoral arterial stenosis None Vascular disorders None View
Hemorrhage None Vascular disorders None View
Hypertension None Vascular disorders None View
Thrombosis None Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache None Nervous system disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Hypertension None Vascular disorders None View
Abdominal pain None Gastrointestinal disorders None View
Diarrhea None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Dyspepsia None Gastrointestinal disorders None View
Constipation None Gastrointestinal disorders None View
Abdominal pain lower None Gastrointestinal disorders None View
Urinary tract infection None Infections and infestations None View
Sinusitis None Infections and infestations None View
Influenza None Infections and infestations None View
Bronchitis None Infections and infestations None View
Nasopharyngitis None Infections and infestations None View
Back pain None Musculoskeletal and connective tissue disorders None View