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 @ 2:02 AM
Ignite Modification Date: 2025-12-26 @ 12:26 AM
NCT ID: NCT01493960
Description: All patients who entered into the study and were treated with at least 1 dose of study drug are included in the safety analysis set.
Frequency Threshold: 3
Time Frame: 1 year, 2 weeks
Study: NCT01493960
Study Brief: The Efficacy and Safety of Cobitolimod (Kappaproct®) in Chronic Active Treatment Refractory Ulcerative Colitis Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cobitolimod 2 doses 4 weeks apart Cobitolimod: 30 mg rectal dose at week 0 and 4 None None 10 87 31 87 View
Placebo 2 doses 4 weeks apart Placebo: Rectal dose at week 0 and 4 None None 8 43 6 43 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 14.1 View
Perirectal abscess NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 14.1 View
Herpes Zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 14.1 View
Clostridial infection NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDra 14.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 14.1 View
Overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 14.1 View
Osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 14.1 View
Spinal compression fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 14.1 View
Sensory Distrurbance NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 14.1 View
Movement disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 14.1 View
Benign Dysplaisa NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDra 14.1 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 14.1 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 14.1 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 14.1 View
Acute Coronary syndrome NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 14.1 View
Myocardial Ischemia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 14.1 View
Glaucoma NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDra 14.1 View
Retinal Veon Thrombosis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDra 14.1 View
Intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 14.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 14.1 View
Cushingoid NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDra 14.1 View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 14.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 14.1 View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 14.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 14.1 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra 14.1 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 14.1 View