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 @ 4:39 PM
Ignite Modification Date:
2025-12-25 @ 2:29 PM
NCT ID:
NCT01557166
Description:
Safety analysis set - included all randomised subjects exposed to trial drug.
Frequency Threshold:
5
Time Frame:
Events that either occur before randomisation and increase in severity during the treatment period or have an onset date on or after the first day of randomised treatment and no later than 14 days after the last day of randomised treatment.
Study:
NCT01557166
Study Brief:
Effect of Liraglutide in Obese Subjects With Moderate or Severe Obstructive Sleep Apnoea: SCALE™ - Sleep Apnoea
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 3.0 mg | Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week. | None | None | 6 | 176 | 117 | 176 | View |
| Placebo | Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week. | None | None | 6 | 179 | 84 | 179 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA, version 15.1 | View |
| Angina unstable | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA, version 15.1 | View |
| Sinus arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA, version 15.1 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA, version 15.1 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA, version 15.1 | View |
| Procedural pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA, version 15.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA, version 15.1 | View |
| Bone lesion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA, version 15.1 | View |
| Prostate cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 15.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA, version 15.1 | View |
| Depression suicidal | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA, version 15.1 | View |
| Nightmare | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA, version 15.1 | View |
| Sleep apnoea syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA, version 15.1 | View |
| Coronary revascularisation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA, version 15.1 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA, version 15.1 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, version 15.1 | View |
| Obstruction gastric | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, version 15.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA, version 15.1 | View |
| Spinal fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA, version 15.1 | View |
| Oropharyngeal swelling | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA, version 15.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, version 15.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, version 15.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, version 15.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, version 15.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, version 15.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, version 15.1 | View |
| Injection site haematoma | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA, version 15.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA, version 15.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA, version 15.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA, version 15.1 | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA, version 15.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA, version 15.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA, version 15.1 | View |