Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 9:19 PM
Ignite Modification Date: 2025-12-25 @ 7:06 PM
NCT ID: NCT01976104
Description: Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.
Frequency Threshold: 5
Time Frame: From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months
Study: NCT01976104
Study Brief: Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Undergoing an Elective Procedure
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
60 mg Placebo (Lower Baseline Platelet Count) Participants with a baseline platelet count of less than 40 x 10\^9/liters (L) took three 20 milligrams (mg) matching placebo tablets orally, once daily with a meal on Days 1 through 5. 0 None 1 43 22 43 View
60 mg Avatrombopag (Lower Baseline Platelet Count) Participants with a baseline platelet count of less than 40 x 10\^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5. 0 None 1 70 30 70 View
40 mg Placebo (Higher Baseline Platelet Count) Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\^9/L took two 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5. 1 None 1 33 15 33 View
40 mg Avatrombopag (Higher Baseline Platelet Count) Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5. 0 None 1 57 14 57 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA (19.1) View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (19.1) View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (19.1) View
Ileus paralytic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (19.1) View
Hepatic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (19.1) View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (19.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (19.1) View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (19.1) View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (19.1) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (19.1) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA (19.1) View
Puncture site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA (19.1) View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA (19.1) View
Transfusion reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (19.1) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (19.1) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (19.1) View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (19.1) View