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 @ 5:08 PM
Ignite Modification Date: 2025-12-25 @ 2:46 PM
NCT ID: NCT04473950
Description: None
Frequency Threshold: 0
Time Frame: 2 sessions were held approximately 1 week apart. Adverse events were collected after receiving the first injection of study medication until 24 hours after the last session. This was approximately 8 days for participants assuming sessions were held one week apart.
Study: NCT04473950
Study Brief: The Effect of Chronic Pain on Delay Discounting in Methadone Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pain Group, Placebo Session Patients with chronic pain who are maintained on methadone for opioid use disorder. Placebo: An IM injection of 0.9% normal saline will be given. 0 None 0 6 1 6 View
Pain Group, Naloxone Session Patients with chronic pain who are maintained on methadone for opioid use disorder. Naloxone Hydrochloride: An intramuscular (IM) injection of naloxone will be given. 0 None 0 6 2 6 View
No Pain Group, Placebo Session Patients who are maintained on methadone for opioid use disorder but who do not have chronic pain. Naloxone Hydrochloride: An intramuscular (IM) injection of naloxone will be given. 0 None 0 4 1 4 View
No Pain Group, Naloxone Session Patients who are maintained on methadone for opioid use disorder but who do not have chronic pain. Placebo: An IM injection of 0.9% normal saline will be given. 0 None 0 4 0 4 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Tunnel Vision NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (Unspecified) View
Paranoia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Eye Irritation NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (Unspecified) View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View