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 @ 2:16 PM
Ignite Modification Date: 2025-12-25 @ 12:54 PM
NCT ID: NCT00911495
Description: None
Frequency Threshold: 5
Time Frame: 28 days
Study: NCT00911495
Study Brief: Study of Intravenous GMI-1070 in Adults With Sickle Cell Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
GMI-1070 GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening None None 0 15 9 15 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache None Nervous system disorders None View
Anemia None Blood and lymphatic system disorders None View
Leukocytosis None Blood and lymphatic system disorders None View
sickle cell anemia with crisis None Congenital, familial and genetic disorders None View
vomiting None Gastrointestinal disorders None View
infusion site pain None General disorders None View
arthralgia None Musculoskeletal and connective tissue disorders None View
cough None Respiratory, thoracic and mediastinal disorders None View
oropharyngeal pain None Respiratory, thoracic and mediastinal disorders None View
pruritus None Skin and subcutaneous tissue disorders None View
hypokalemia None Metabolism and nutrition disorders None View