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: 2025-12-24 @ 9:12 PM
Ignite Modification Date: 2025-12-25 @ 7:01 PM
NCT ID: NCT03345004
Description: None
Frequency Threshold: 5
Time Frame: Treatment-emergent adverse events, from start of Diamyd/Placebo treatment until Month 24.
Study: NCT03345004
Study Brief: Diamyd Administered Into Lymph Nodes in Combination With Vitamin D in Type 1 Diabetes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Active Arm Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) 0 None 0 57 18 57 View
Placebo Arm Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120) 0 None 3 52 12 52 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Jaw fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (20.1) View
Diabetes Mellitus inadequate control SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (20.1) View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (20.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (20.1) View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (20.1) View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA (20.1) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (20.1) View