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 @ 4:40 PM
Ignite Modification Date: 2025-12-25 @ 2:29 PM
NCT ID: NCT03020966
Description: Patients with a high likelihood to experience serious adverse effects, have pre-existing conditions which may put the patient at risk for adverse effects, or have contradictions to the medications in this study were not enrolled. The likelihood of serious risks occurring is low since the required doses are not high enough to cause adverse liver damage. Furthermore, the dosage of acetaminophen will be closely monitored.
Frequency Threshold: 0
Time Frame: 3 days
Study: NCT03020966
Study Brief: IV vs. Oral Acetaminophen as a Component of Multimodal Analgesia After Total Hip Arthroplasty
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Oral Tylenol Patient group receiving 1000mg of oral acetaminophen and an intravenous placebo Acetaminophen: Oral acetaminophen, intravenous placebo 0 None 0 75 0 75 View
Intravenous Tylenol Patient group receiving 1000mg of intravenous acetaminophen and an oral placebo Acetaminophen: Intravenous acetaminophen, oral placebo 0 None 0 76 0 76 View
Serious Events(If Any):
Other Events(If Any):