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 @ 2:25 AM
Ignite Modification Date: 2025-12-26 @ 12:58 AM
NCT ID: NCT05148234
Description: 1/2 participants were enrolled but not treated.
Frequency Threshold: 0
Time Frame: From first study intervention, study day 1, through study day 100 after after the end of the treatment cycle; approximately 7 months.
Study: NCT05148234
Study Brief: BMS-986253 in Myelodysplastic Syndromes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Phase I Dose Level 1: 1200mg Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants. Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6. Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6. BMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration product label. 0 None 1 1 1 1 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (5.0) View
Osteonecrosis of jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (5.0) View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View