Adverse Events Module

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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 @ 11:27 PM
NCT ID: NCT02596893
Description: Maximum treatment duration was 52.6 weeks
Frequency Threshold: 5
Time Frame: From day 1 of GED-0301 until 28 days after the last dose of IP as well as those SAEs made known to the Investigator at any time thereafter that are suspected of being related to IP.
Study: NCT02596893
Study Brief: Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active 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
Placebo Participants received placebo daily up to week 52. 0 None 16 174 78 174 View
GED-0301 160 mg / GED-0301 40 mg 4 Week Alt Participants received GED-0301 160 mg daily for 12 weeks, followed by alternating placebo daily for 4 weeks and GED-0301 40 mg daily for 4 weeks, up to week 52. 0 None 28 176 72 176 View
GED-0301 160 mg / GED-0301 40 mg Participants received GED-0301 160 mg daily for 12 weeks, followed by continuous GED-0301 40 mg daily, up to week 52. 1 None 22 176 74 176 View
GED-0301 160 mg / GED-0301 160 mg 4 Week Alt Participants received 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, up to week 52. 1 None 15 175 63 175 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
ABDOMINAL ADHESIONS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
ANAL FISSURE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
ANAL FISTULA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
COLITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
CROHN'S DISEASE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
ENTEROVESICAL FISTULA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
HAEMATOCHEZIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
ILEAL STENOSIS 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
LARGE INTESTINE PERFORATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
MELAENA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
PANCREATITIS ACUTE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
SMALL INTESTINAL OBSTRUCTION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
ASTHENIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
DRUG WITHDRAWAL SYNDROME SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
CHOLECYSTITIS ACUTE SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20.0 View
HEPATIC VEIN THROMBOSIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20.0 View
HEPATITIS SYSTEMATIC_ASSESSMENT Hepatobiliary 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
CELLULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
EPSTEIN-BARR VIRUS INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
GASTROENTERITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
GASTROENTERITIS NOROVIRUS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
HERPES SIMPLEX OESOPHAGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
HERPES ZOSTER SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
STAPHYLOCOCCAL SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
POST PROCEDURAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
PROCEDURAL INTESTINAL PERFORATION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
THORACIC VERTEBRAL FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
WEIGHT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
MALNUTRITION SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
MUSCULOSKELETAL PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
CERVIX NEOPLASM SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
NEUROENDOCRINE TUMOUR SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
SCIATICA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
DEVICE DISLOCATION SYSTEMATIC_ASSESSMENT Product Issues MedDRA 20.0 View
ALCOHOLISM SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
STRESS URINARY INCONTINENCE SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.0 View
PERINEAL DISORDER SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 20.0 View
ACUTE FEBRILE NEUTROPHILIC DERMATOSIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
PSORIASIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
PYODERMA GANGRENOSUM SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ABDOMINAL PAIN 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
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
VIRAL UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View