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 @ 10:51 PM
Ignite Modification Date: 2025-12-25 @ 8:20 PM
NCT ID: NCT00495469
Description: Safety Population was used for reporting all AEs
Frequency Threshold: 5
Time Frame: AEs were reported up to Week 14
Study: NCT00495469
Study Brief: Dose-Ranging Study In Subjects With Type 2 Diabetes Mellitus Who Are Treatment-Naive
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 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks. 0 None 0 36 3 36 View
GSK189075 100 mg QD Participants received 2 tablets of GSK189075 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. 0 None 1 37 9 37 View
GSK189075 250 mg QD Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. 0 None 0 34 11 34 View
GSK189075 500 mg QD Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. 0 None 0 36 6 36 View
GSK189075 1000 mg QD Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. 0 None 0 36 17 36 View
GSK189075 250 mg BID Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks. 0 None 1 36 7 36 View
Pioglitazone 30 mg QD Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks. 0 None 0 35 7 35 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 11.0 View
Scapula fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Vaginal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Tendonitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View