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 @ 3:26 PM
Ignite Modification Date:
2025-12-25 @ 1:43 PM
NCT ID:
NCT02641392
Description:
Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose
Frequency Threshold:
5
Time Frame:
From the first day of GED-0301 up tol 28 days after the last dose of GED-0301.
Study:
NCT02641392
Study Brief:
A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| GED-0301 40 mg 4 Weeks Alt | Participants received alternating placebo daily for 4 weeks and GED-0301 40 mg daily for 4 weeks, up to week 208 | 0 | None | 1 | 4 | 1 | 4 | View |
| GED-0301 40 mg | Participants received continuous GED-0301 40 mg daily, up to week 208. | 0 | None | 0 | 13 | 6 | 13 | View |
| GED-0301 160 mg 4 Weeks Alt | Participants received one of three dose regimens up to week 208: 1\) alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks or (2) alternating GED-0301 160 mg daily for 4 weeks and placebo daily for 4 weeks or (3) GED-0301 160 mg daily for 12 weeks, followed by alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks | 1 | None | 41 | 293 | 92 | 293 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.0 | View |
| ANAL FISTULA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| INTESTINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| INTESTINAL STENOSIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| LARGE INTESTINAL STENOSIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| ANAL STENOSIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| CROHN'S DISEASE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| ILEAL STENOSIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| RECTAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| SMALL INTESTINAL OBSTRUCTION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| SUBILEUS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| DROWNING | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| HYPERTHERMIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| ABDOMINAL ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| ANAL ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| APPENDICITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| CAMPYLOBACTER GASTROENTERITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| GROIN ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| INFECTIOUS COLITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| PERIRECTAL ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| POSTOPERATIVE ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| PULMONARY SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| SALMONELLOSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| VULVAL ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| ANASTOMOTIC ULCER HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| ELECTROCARDIOGRAM T WAVE INVERSION | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| HEPATIC ENZYME INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| ANKYLOSING SPONDYLITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| VESICAL FISTULA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20.0 | View |
| ACUTE FEBRILE NEUTROPHILIC DERMATOSIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| CARDIAC VALVE DISEASE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| ANAL FISTULA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| CROHN'S DISEASE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| ILEAL STENOSIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| GALLBLADDER DISORDER | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 20.0 | View |
| CYSTITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| RADIUS FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| ELECTROCARDIOGRAM T WAVE INVERSION | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| HYPERLIPIDAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.0 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| APHTHOUS ULCER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |