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 @ 5:34 PM
Ignite Modification Date:
2025-12-25 @ 3:06 PM
NCT ID:
NCT01800968
Description:
All serious adverse events documented from baseline to day 210. According to protocol: Non-serious adverse events will not be collected on the eCRF but should be documented in source documents and followed according to local standard of care. Non-serious adverse events were not reported to sponsor, and therefore not reported.
Frequency Threshold:
5
Time Frame:
Baseline to day 210.
Study:
NCT01800968
Study Brief:
Functional Impact of GLP-1 for Heart Failure Treatment (FIGHT)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Liraglutide | Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous (SQ) daily. Liraglutide: Active Drug | None | None | 33 | 154 | 0 | 0 | View |
| Placebo | Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous (SQ) daily. Placebo: Placebo | None | None | 33 | 146 | 0 | 0 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (18.0) | View |
| Angina pectoris | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.0) | View |
| Gastrointentinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Pancreatitis acute | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Pancreatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.0) | View |
| Gout | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.0) | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.0) | View |
| Asthma | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.0) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| International Normalised Ratio Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.0) | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Hernia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.0) | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Viral Rash | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Spinal compression fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Hyperolmolar Hyperglycaemic State | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.0) | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| Non-cardiac chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.0) | View |
| Diverticulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Hypoglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.0) | View |
| Hepatic Encephalopathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.0) | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Toxicity to various agents | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Musculoskeletal Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | View |
| Prostate Cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | View |
| Hypoglycaemic unconsciousness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.0) | View |
| Abortion spontaneous | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | View |
Other Events(If Any):