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 @ 1:15 AM
Ignite Modification Date: 2025-12-25 @ 11:24 PM
NCT ID: NCT04190693
Description: None
Frequency Threshold: 0
Time Frame: Throughout the study period (24 weeks)
Study: NCT04190693
Study Brief: IMCY-T1D-002: Long-term Follow-up Study of T1D Patients Previously Treated With IMCY-0098 or Placebo
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 Patients having received 50 μg IMP (2x subcutaneous \[s.c.\] injections of 25 μg \[100 μL each\]) + 3x 25 μg IMP (each as 2x s.c. injections of 12.5 μg \[50 μL each\]) in study 2016-003514-27 0 None 0 4 2 4 View
Cohort 2 Patients having received 150 μg IMP (2x s.c. injections of 75 μg \[300 μL each\]) + 3x 75 μg IMP (each as 2x s.c injections of 12.5 μg \[150 μL each\]) in study 2016-003514-27 0 None 0 7 3 7 View
Cohort 3 Patients having received 450 μg IMP (2x s.c. injections of 225 μg \[900 μL each\]) + 3x 225 μg IMP (each as 2x s.c injections of 112.5 μg \[450 μL each\]) in study 2016-003514-27 0 None 0 12 6 12 View
Placebo Patients having received Placebo in study 2016-003514-27 0 None 0 7 2 7 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Foreign body in eye NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Sports injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral swelling NON_SYSTEMATIC_ASSESSMENT General disorders None View
Adbominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Genital rash NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Diabetes mellitus NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bacterial infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fungal ski infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View