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 @ 1:50 PM
Ignite Modification Date: 2025-12-25 @ 12:42 PM
NCT ID: NCT04056195
Description: At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
Frequency Threshold: 5
Time Frame: Up to 16 weeks
Study: NCT04056195
Study Brief: Study of Oral SKI-O-703, SYK Inhibitor, in Patients With Persistent and Chronic Immune Thrombocytopenia (ITP)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SKI-O-703 200 mg BID 2 capsules of 100 mg SKI-O-703 BID (twice per day) 0 None 0 26 15 26 View
SKI-O-703 400 mg BID 4 capsules of 100 mg SKI-O-703 BID (twice per day) 0 None 2 22 17 22 View
Placebo 4 capsules of placebo BID (twice per day) 0 None 3 12 8 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (21.0) View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Coronavirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Guillain-Barre syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (21.0) View
Corona virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (21.0) View
Gingival bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.0) View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (21.0) View