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 @ 4:47 AM
Ignite Modification Date: 2025-12-26 @ 3:49 AM
NCT ID: NCT06655818
Description: Safety set included all participants who received at least 1 dose of any component of the combination therapy.
Frequency Threshold: 5
Time Frame: All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 153 weeks.
Study: NCT06655818
Study Brief: Sub-study of Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Dostarlimab (GSK4057190) in Participants With RRMM
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 500 mg dostarlimab as a 30-minute IV infusion 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles (Q3W). 2 None 2 4 4 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.0 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v25.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v25.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v25.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v25.0 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v25.0 View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v25.0 View
Foreign body sensation in eyes SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v25.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v25.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v25.0 View