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 @ 11:24 PM
Ignite Modification Date: 2025-12-25 @ 9:09 PM
NCT ID: NCT01136356
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01136356
Study Brief: A Within Subject Comparison of Opioid Withdrawal in Opioid Dependent Individuals
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All Participants The adverse events were not specified per drug intervention, therefore, the adverse events per interventions is unknown. The data below references the adverse events recorded by licensed nursing personnel during the participants' 59-day protocol in a residential research unit. All participants (N=7) were randomized to receive either buprenorphine (32 mg/day i.m.) or morphine (120 mg/day i.m.) administered in four divided doses each day for 9 days (8 mg of buprenorphine four times per day, or 30 mg of morphine four times per day). Participants then underwent an 18-day period of spontaneous opioid withdrawal, during which four double blind i.m. placebo injections were administered daily. After the period of spontaneous withdrawal, participants received the second opioid administration and spontaneous withdrawal period using the same time course described above. None None 0 12 4 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea None Gastrointestinal disorders None View
Indigestion None Gastrointestinal disorders None View
Lacrimation Increased None Eye disorders None View
Chills None General disorders None View
Insomnia None Psychiatric disorders None View
Headache None General disorders None View