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 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
NCT ID:
NCT01077193
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT01077193
Study Brief:
Surgical Intervention in Bariatric Patients: Excess Weight Loss in the Morbidly Obese Following Gastric Plication
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Gastric Plication Surgery | Gastric Plication : A laparoscope will be inserted to visualize the surgical area and confirm absence of injury to any surrounding organ or structure. A flexible endoscope will be passed transorally into the gastric lumen to provide insufflation. The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3cm from the pylorus and ending at or near the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected. At least two rows of at least five continuous stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. An endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure. | None | None | 8 | 44 | 43 | 44 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA | View |
| Atrioventricular block | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA | View |
| Left ventricular hypertrophy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| Gastric perforatin | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA | View |
| Abdominal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA | View |
| Epicondylitis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA | View |
| Incisional hernia | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA | View |
| Joint sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA | View |
| Overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Bladder obstruction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA | View |
| Benign prostatic hyperplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA | View |
| Atelectasis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Haemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | None | Gastrointestinal disorders | MedDRA | View |
| Abdominal pain | None | Gastrointestinal disorders | MedDRA | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA | View |
| Gastrooesophageal reflux disease | None | Gastrointestinal disorders | MedDRA | View |
| Constipation | None | Gastrointestinal disorders | MedDRA | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Alopecia | None | Skin and subcutaneous tissue disorders | MedDRA | View |
| Abdominal pain upper | None | Gastrointestinal disorders | MedDRA | View |
| Dyspepsia | None | Gastrointestinal disorders | MedDRA | View |
| Cholelithiasis | None | Hepatobiliary disorders | MedDRA | View |
| Urinary tract infection | None | Infections and infestations | MedDRA | View |
| Hiatus hernia | None | Gastrointestinal disorders | MedDRA | View |
| Non-cardiac chest pain | None | General disorders | MedDRA | View |
| Musculoskeletal pain | None | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Dizziness | None | Nervous system disorders | MedDRA | View |
| Headache | None | Nervous system disorders | MedDRA | View |
| Hypertension | None | Vascular disorders | MedDRA | View |
| Procedural pain | None | Injury, poisoning and procedural complications | MedDRA | View |
| Body temperature increased | None | Investigations | MedDRA | View |