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 @ 1:39 AM
Ignite Modification Date: 2025-12-25 @ 11:55 PM
NCT ID: NCT03169894
Description: None
Frequency Threshold: 0
Time Frame: All adverse events were collected from the time of the informed consent until the final safety follow-up visit (Day 84 or 28 days after Early Termination). This included events occurring during the screening phase of the study, regardless of whether investigational product was administered. Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent.
Study: NCT03169894
Study Brief: Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease or Ulcerative Colitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort 1 MDGN-002 1.0 mg/kg 0 None 1 4 2 4 View
Cohort 2 MDGN-002 3.0 mg/kg 0 None 1 4 3 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Microcytic anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (23.0) View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (23.0) View
Abdominal pain lower NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (23.0) View
Crohn's disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (23.0) View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (23.0) View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (23.0) View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (23.0) View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (23.0) View
Malnutrition NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (23.0) View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (23.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (23.0) View
Gastroenteritis viral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (23.0) View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (23.0) View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (23.0) View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (23.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (23.0) View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (23.0) View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (23.0) View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (23.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (23.0) View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (23.0) View
Body temperature increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (23.0) View
Cachexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (23.0) View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (23.0) View
Tunnel vision NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (23.0) View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (23.0) View
Night sweats NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (23.0) View
Hot flush NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (23.0) View