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 @ 1:32 PM
Ignite Modification Date: 2025-12-25 @ 12:33 PM
NCT ID: NCT01311895
Description: The discrepancy between the number of patients enrolled and randomized and those included in analysis is due to the following. H2O group: never given IV opioids (2), received ketorolac or additional opioids within the 60 min (7). 1+1 group: missing data (3), didn't receive 2nd dose within 60 min (2), received additional opioids within 60 min (2)
Frequency Threshold: 0
Time Frame: 60 minutes
Study: NCT01311895
Study Brief: Clinical Trial Comparing Two Protocols Using Intravenous (IV) Hydromorphone
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
H2O (2 mg IV Hydromorphone) 2 mg IV hydromorphone H2O: 2 mg IV hydromorphone 0 None 0 166 56 166 View
1+1 (1 mg IV Hydromorphone + Optional 1 mg IV Hydromorphone) 1 mg IV hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the following question: "Do you want more pain medication?" 1+1: 1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the question, "Do you want more pain medication?" 0 None 0 168 53 168 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Administration of naloxone None Endocrine disorders None View
Oxygen saturation <95% None Respiratory, thoracic and mediastinal disorders None View
Pulse rate <50 beats/min None Cardiac disorders None View
Systolic blood pressure <90 mmHg None Vascular disorders None View
Pruritus None Skin and subcutaneous tissue disorders None View
Nausea None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View