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 @ 7:56 PM
Ignite Modification Date: 2025-12-25 @ 5:31 PM
NCT ID: NCT01183104
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01183104
Study Brief: START-J: SiTAgliptin in eldeRly Trial in Japan
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sitagliptin Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=\< \<50). None None 13 148 33 148 View
Glimepiride Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg None None 3 143 31 143 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infectious enteritis None Infections and infestations None View
Cerebral infarction None Nervous system disorders None View
Complete atrioventricular block None Cardiac disorders None View
Dermatitis exfoliative None Skin and subcutaneous tissue disorders None View
Trismus None Musculoskeletal and connective tissue disorders None View
Globe rupture None Injury, poisoning and procedural complications None View
Pneumonia None Infections and infestations None View
Acute myeloid leukemia None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Tongue neoplasm malignant stage unspecified None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Hemorrhagic diathesis None Blood and lymphatic system disorders None View
Hyphema None Eye disorders None View
Acute myocardial infarction None Cardiac disorders None View
Takotsubo cardiomyopathy None Cardiac disorders None View
Colon polyp None Gastrointestinal disorders None View
Osteoarthritis None Musculoskeletal and connective tissue disorders None View
Renal failure None Renal and urinary disorders None View
Death None General disorders None View
Radius fracture None Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Intestinal abscess None Infections and infestations None View
Appendicitis None Infections and infestations None View
Bronchitis None Infections and infestations None View
Cystitis None Infections and infestations None View
Herpes zoster None Infections and infestations None View
Nasopharyngitis None Infections and infestations None View
Pharyngitis None Infections and infestations None View
Helicobacter infection None Infections and infestations None View
Bile ｄuct ｃancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Colon ｃancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Polycythemia vera None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Thyroid neoplasm None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Anemia None Blood and lymphatic system disorders None View
Mediastinal lymphadenopathy None Blood and lymphatic system disorders None View
Diabetes mellitus inadequate control None Metabolism and nutrition disorders None View
Hyperuricemia None Metabolism and nutrition disorders None View
Hypoglycemia None Metabolism and nutrition disorders None View
Loss of appetite None Metabolism and nutrition disorders None View
Depression None Psychiatric disorders None View
Insomnia None Psychiatric disorders None View
Cerebral infarction None Nervous system disorders None View
Dizziness None Nervous system disorders None View
Hypoesthesia None Nervous system disorders None View
Loss of consciousness None Nervous system disorders None View
Sciatica None Nervous system disorders None View
Allergic conjunctivitis None Eye disorders None View
Pterygium None Eye disorders None View
Retinal hemorrhages None Eye disorders None View
Vision blurred None Eye disorders None View
Tinnitus None Ear and labyrinth disorders None View
Atrial fibrillation None Cardiac disorders None View
Heart failure None Cardiac disorders None View
Myocardial ischemia None Cardiac disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Allergic rhinitis None Respiratory, thoracic and mediastinal disorders None View
Upper respiratory tract inflammation None Respiratory, thoracic and mediastinal disorders None View
Abdominal pain upper None Gastrointestinal disorders None View
Constipation None Gastrointestinal disorders None View
Diarrhea None Gastrointestinal disorders None View
Gastric ulcer None Gastrointestinal disorders None View
Erosive gastritis None Gastrointestinal disorders None View
Gastroesophageal reflux disease None Gastrointestinal disorders None View
Hemorrhoid None Gastrointestinal disorders None View
Stomatitis None Gastrointestinal disorders None View
Choledocholith None Hepatobiliary disorders None View
Cholelithiasis None Hepatobiliary disorders None View
Liver Cyst None Hepatobiliary disorders None View
Hepatic function abnormal None Hepatobiliary disorders None View
Eczema None Skin and subcutaneous tissue disorders None View
Pruritus None Skin and subcutaneous tissue disorders None View
Seborrheic dermatitis None Skin and subcutaneous tissue disorders None View
Hives None Skin and subcutaneous tissue disorders None View
Back pain None Musculoskeletal and connective tissue disorders None View
Osteoporosis None Musculoskeletal and connective tissue disorders None View
Spinal stenosis None Musculoskeletal and connective tissue disorders None View
Spondylosis deformans None Musculoskeletal and connective tissue disorders None View
Hygroma None Musculoskeletal and connective tissue disorders None View
Tenovaginitis None Musculoskeletal and connective tissue disorders None View
Disc protrusion None Musculoskeletal and connective tissue disorders None View
Ureteral calculus None Renal and urinary disorders None View
Face edema None General disorders None View
Malaise None General disorders None View
Fever None General disorders None View
Blood pressure increased None Investigations None View
Blood uric acid increased None Investigations None View
Platelet count decreased None Investigations None View
T-wave abnormality None Investigations None View
Injury None Injury, poisoning and procedural complications None View
Sprained ligament None Injury, poisoning and procedural complications None View
Wrist join fraction None Injury, poisoning and procedural complications None View
Ureteral stone removal None Surgical and medical procedures None View
Dental care None Surgical and medical procedures None View
Cataract operation None Surgical and medical procedures None View