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 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
NCT ID:
NCT00796367
Description:
None
Frequency Threshold:
2
Time Frame:
AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Study:
NCT00796367
Study Brief:
A Safety and Efficacy Study of VI-0521 to Evaluate the Long Term Treatment of Obesity in Adults With Obesity-Related Co-Morbid Conditions. An Extension Study of Protocol OB-303 (NCT00553787)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo | Placebo | None | None | 9 | 227 | 182 | 227 | View |
| VI-0521 Mid | VI-0521 7.5 mg PHEN/46 mg TPM | None | None | 4 | 153 | 111 | 153 | View |
| VI-0521 Top | VI-0521 15 mg PHEN/92 mg TPM | None | None | 13 | 295 | 234 | 295 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ankle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.1) | View |
| humerus fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.1) | View |
| hemorrhage intracranial | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.1) | View |
| transient ischemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.1) | View |
| cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.1) | View |
| depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.1) | View |
| peptic ulcer hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| nephritic syndrome | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.1) | View |
| pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.1) | View |
| ischemic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.1) | View |
| inguinal hernia, obstructive | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| abdominal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| renal failure, acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.1) | View |
| pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| mesothelioma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | View |
| drug hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (10.1) | View |
| arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | View |
| osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | View |
| serositis | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.1) | View |
| myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.1) | View |
| acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.1) | View |
| cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (10.1) | View |
| acute cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (10.1) | View |
| cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (10.1) | View |
| uterine prolapse | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (10.1) | View |
| benign prostatic hyperplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (10.1) | View |
| cervical dysplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (10.1) | View |
| respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | View |
| back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | View |
| myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | View |
| diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| tooth ache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.1) | View |
| anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.1) | View |
| diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.1) | View |
| upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.1) | View |
| procedural pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.1) | View |
| musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | View |
| pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| gastroenteritis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| ear infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| tooth abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| tooth infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | View |
| muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | View |
| abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| hemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| joint sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.1) | View |
| muscle strain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.1) | View |
| contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.1) | View |
| cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
| pharyngolaryngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
| sinus congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
| headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.1) | View |
| paresthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.1) | View |
| dyslipidemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.1) | View |
| weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.1) | View |
| hemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.1) | View |
| abdominal bruit | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.1) | View |
| edema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.1) | View |
| eye pain | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.1) | View |
| hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.1) | View |
| seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (10.1) | View |