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 @ 1:46 AM
Ignite Modification Date: 2025-12-26 @ 12:04 AM
NCT ID: NCT01868594
Description: Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=151, Safety Population)
Frequency Threshold: 0
Time Frame: Adverse/Serious adverse events were registered during 36 weeks of therapy and 30 days after the end of therapy.
Study: NCT01868594
Study Brief: Clinical Trial of Efficacy and Safety of Subetta in the Combined Treatment of Patients With Type I Diabetes Mellitus
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Subetta Standard therapy of type I diabetes mellitus + Subetta (1 tablet 4 times a day). Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime). Subetta: Efficacy and Safety of Subetta in the combined treatment of patients with type I diabetes mellitus None None 2 76 16 76 View
Placebo Standard therapy of type I diabetes mellitus + Placebo (1 tablet 4 times a day). Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime). Placebo None None 3 75 18 75 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fracture of humerus SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Parotid abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Chronic venous insufficiency SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Varicose veins of lower extremities SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Type I diabetes mellitus with ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypertension arterial SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Inflammation of inguinal lymphonodus on the right SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Goiter SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Subclinical hypothyreoidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Bacterial food poisoning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Heartburn SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Epigastric pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dentalgia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Increase in body temperature to 38.5 C SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Increase in body temperature up to 38.2 ะก SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Diabetic hepatosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Allergic reactions SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Angina SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Acute respiratory viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Acute respiratory disease SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Acute bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Parodontosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Epididymitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Contusion of the hand SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Palpitations SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Increased blood pressure to 150/90 mm Hg, headache, nausea SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Increased body temperature SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Fasting hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Pain in the shoulder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Heavy legs SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Leg cramps SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Cervicalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
Vasomotor rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Throat irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Increased blood pressure SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View