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 @ 3:11 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
NCT ID:
NCT02096705
Description:
Includes serious adverse events with onset on or after the first date/time of double-blind treatment and on or prior to the last day of double blind treatment plus 30 days. Includes non-serious adverse events with onset on or after the first date/time of double-blind treatment and on or prior to the last day of double blind treatment plus 4 days.
Frequency Threshold:
5
Time Frame:
24 week treatment period + 30 days
Study:
NCT02096705
Study Brief:
Phase III Insulin Add-On Asia Regional Program - ST
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Dapagliflozin | Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin | None | None | 8 | 139 | 61 | 139 | View |
| Placebo | Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin | None | None | 18 | 133 | 61 | 133 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ACUTE MYOCARDIAL INFARCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.1) | View |
| ANGINA PECTORIS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.1) | View |
| CORONARY ARTERY DISEASE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.1) | View |
| MYOCARDIAL BRIDGING | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (18.1) | View |
| CATARACT | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (18.1) | View |
| UVEITIS | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (18.1) | View |
| GASTRITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| LUNG INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| NEUROSYPHILIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| HUMERUS FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.1) | View |
| ACIDOSIS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.1) | View |
| HYPERGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.1) | View |
| FOOT DEFORMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| OSTEOARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| PERIARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| SPINAL OSTEOARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| BILE DUCT CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | View |
| COLORECTAL CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | View |
| PROSTATE CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | View |
| ARACHNOID CYST | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| CEREBRAL INFARCTION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| DIABETIC NEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| SEIZURE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| SYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| VIITH NERVE PARALYSIS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| ECTOPIC PREGNANCY | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (18.1) | View |
| CALCULUS URETERIC | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (18.1) | View |
| HYDRONEPHROSIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (18.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| DYSLIPIDAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.1) | View |
| HYPERLIPIDAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.1) | View |
| HYPERURICAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.1) | View |