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 @ 2:33 PM
Ignite Modification Date: 2025-12-25 @ 1:05 PM
NCT ID: NCT01869959
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01869959
Study Brief: A Study of LY2405319 in Participants With Type 2 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
3 mg LY2405319 Participants received 3 mg LY2405319 injected SC once daily for 28 days. None None 0 11 7 11 View
10 mg LY2405319 Participants received 10 mg LY2405319 injected SC once daily for 28 days. None None 0 10 8 10 View
20 mg LY2405319 Participants received 20 mg LY2405319 injected SC once daily for 28 days. None None 2 15 11 15 View
Placebo Participants received placebo-matching LY2405319 injected SC once daily for 28 days. None None 1 10 9 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Optic ischaemic neuropathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 11.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 11.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Application site rash SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection site bruising SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection site induration SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection site inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection site irritation SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection site warmth SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Scratch SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Blood calcium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Increased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection site urticaria SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Dysaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View