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 @ 4:17 AM
Ignite Modification Date: 2025-12-26 @ 3:18 AM
NCT ID: NCT02829320
Description: On-treatment SAEs and non-serious AEs are reported for All Treated Subjects Population.
Frequency Threshold: 5
Time Frame: On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until Week 24.
Study: NCT02829320
Study Brief: Efficacy and Safety Study of GSK1278863 in Japanese Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease Who Are Not Taking Erythropoiesis Stimulating Agents
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All Participants Participants with newly started dialysis (dialysis newly started \<12 weeks before screening) or with maintenance dialysis (dialysis started \>=12 weeks before screening) received GSK1278863 orally once daily initially at 4 mg for 4 weeks from Day 1. Subsequently, participants received GSK1278863 orally once a day according to a pre-defined study treatment dose adjustment algorithm to achieve or maintain Hgb within the target range (10.0-12.0 g/dL). In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%. 0 None 3 28 12 28 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Shunt occlusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.1 View
Device dislocation SYSTEMATIC_ASSESSMENT Product Issues MedDRA 20.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Infected dermal cyst SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Shunt stenosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.1 View