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 @ 4:48 PM
Ignite Modification Date: 2025-12-25 @ 2:34 PM
NCT ID: NCT01357850
Description: AEs and non-serious AEs are reported for members of the All subjects Population, comprised of all participants randomized to treatment, who have taken at least one dose of study medication.
Frequency Threshold: 5
Time Frame: Serious adverse events (SAEs) and non-serious AEs collected from the start of study medication and within 30 days after the end of study medication (Week 13) are reported.
Study: NCT01357850
Study Brief: A Multi-center, Placebo-controlled Study to Evaluate the Safety of GSK716155 and Its Effects on Myocardial Metabolism, Myocardial Function, and Exercise Capacity in Patients With NYHA Class II/III Congestive Heart Failure
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. None None 4 30 22 30 View
Albiglutide 30 mg Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. None None 0 27 19 27 View
Albiglutide 3.75 mg Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. None None 2 12 11 12 View
Albiglutide 15 mg Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. None None 2 13 11 13 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac Failure Congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Ventricular Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Small Intestinal Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Device Malfunction SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Procedural Vomiting SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Vulvovaginal mycotic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Osteopenia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site haematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Implant site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Ventricular extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnoea paroxysmal nocturnal SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Hypoventilation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rales SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood urea increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
International normalised ratio increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Brain natriuretic peptide increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Impaired fasting glucose SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Increased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Acne cystic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Actinic keratosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Seborrhoeic dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Excoriation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Eosinophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Breast tenderness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View