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 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
NCT ID:
NCT01708902
Description:
None
Frequency Threshold:
5
Time Frame:
From first drug administration (week 1) until end of treatment, up to 24 weeks
Study:
NCT01708902
Study Brief:
Study to Compare the Efficacy and Safety of Administration of the Fix Dose Combination of Linagliptin Plus Metformin in Drug naïve Type 2 Patients
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Main: Linagliptin 2.5mg / Metformin 500mg BID | Main Group: Patients twice daily received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet. | None | None | 1 | 147 | 32 | 147 | View |
| APG: Linagliptin 5mg After Week 12 | Additional parallel group (APG): Patients once daily received linagliptin 5mg QD, administered oral as tablet. Data from week 12 to week 24 | None | None | 0 | 33 | 2 | 33 | View |
| Main: Linagliptin 5mg QD | Main Group: Patients once daily received linagliptin 5mg QD, administered oral as tablet. | None | None | 2 | 147 | 30 | 147 | View |
| Main: Metformin 500mg BID | Main Group: Patients twice daily received metformin 500mg BID, administered oral as tablet. | None | None | 1 | 145 | 31 | 145 | View |
| Main: Metformin 1000mg BID | Main Group: Patients twice daily received metformin 1000mg BID, administered oral as tablet. | None | None | 2 | 144 | 42 | 144 | View |
| Main: Linagliptin 2.5mg / Metformin 1000mg BID | Main Group: Patients twice daily received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet. | None | None | 4 | 147 | 41 | 147 | View |
| APG: Linagliptin 5mg QD up to Week 12 | Additional parallel group (APG): Patients once daily received linagliptin 5mg QD, administered oral as tablet. (Data up to week 12) | None | None | 1 | 71 | 20 | 71 | View |
| APG: Linagliptin 2.5mg / Metformin 1000mg BID up to Week 12 | Additional parallel group (APG): Patients twice daily received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet. (Data up to week 12) | None | None | 1 | 72 | 15 | 72 | View |
| APG: Linagliptin 5mg - Linagliptin 2.5mg / Met After Week 12 | Additional parallel group (APG): Patients who received linagliptin 5mg QD, administered oral as tablet during the first 12 weeks and switched to linagliptin 2.5mg and metformin 1000mg (met) BID, administered oral as fixed dose combination (FDC) tablet from week 12 to week 24. Data from week 12 to week 24. | None | None | 1 | 31 | 9 | 31 | View |
| APG: Linagliptin 2.5mg / Metformin 1000mg After Week 12 | Additional parallel group (APG): Patients twice daily received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet. Data from week 12 to week 24. | None | None | 1 | 65 | 9 | 65 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MEDDRA 17.0 | View |
| Acute coronary syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA 17.0 | View |
| Otosclerosis | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MEDDRA 17.0 | View |
| Gastric ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Paronychia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 17.0 | View |
| Pharyngotonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 17.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 17.0 | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 17.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 17.0 | View |
| Clavicle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 17.0 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 17.0 | View |
| Foot fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 17.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA 17.0 | View |
| Pituitary tumour | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 17.0 | View |
| Cerebral infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 17.0 | View |
| Lacunar infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 17.0 | View |
| Renal failure acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MEDDRA 17.0 | View |
| Breast disorder | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MEDDRA 17.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 17.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 17.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA 17.0 | View |
| Hyperuricaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA 17.0 | View |
| Dyslipidaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA 17.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 17.0 | View |