Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 12:18 PM
Ignite Modification Date: 2025-12-25 @ 12:02 PM
NCT ID: NCT01098461
Description: On-therapy SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all enrolled participants who received at least one dose of study treatment. Participants were analyzed according to treatment received.
Frequency Threshold: 2
Time Frame: On-therapy serious adverse events (SAEs)/non-serious AEs, with a start date on/after the first day of study medication (SM) and within 56 days after the end of SM, were collected from the start of SM until Follow-up/Early Withdrawal (up to Study Day 168).
Study: NCT01098461
Study Brief: Dose Ranging Study of Albiglutide in Japanese Subjects
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 administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion. None None 2 53 21 53 View
Albiglutide 15 mg Weekly Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion. None None 1 52 27 52 View
Albiglutide 30 mg Weekly Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion. None None 2 54 20 54 View
Albiglutide 30 mg Every Other Week Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion. None None 2 53 23 53 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Deafness neurosensory SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Colon cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Carotid artery stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Renal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Organising pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View