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: 2025-12-25 @ 4:25 AM
Ignite Modification Date: 2025-12-26 @ 3:29 AM
NCT ID: NCT01307020
Description: Analyzed for the Safety population (all patients who received study treatment)
Frequency Threshold: 5
Time Frame: 10 ± 3 days
Study: NCT01307020
Study Brief: Analgesic Effect of Different Combinations of Dexketoprofen Trometamol With Tramadol Hydrochloride in a Model of Moderate to Severe Pain
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DKP-TRIS 12.5mg - TRAM.HCl 37.5mg DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once None None 0 61 7 61 View
DKP-TRIS 12.5mg - TRAM.HCl 75mg DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once None None 0 63 9 63 View
DKP-TRIS 25mg - TRAM.HCl 37.5mg DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once None None 0 63 6 63 View
DKP-TRIS 25mg - TRAM.HCl 75mg DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once None None 0 61 10 61 View
DKP-TRIS 12.5mg DKP-TRIS 12.5mg oral film-coated tablet, once None None 0 60 2 60 View
DKP-TRIS 25mg DKP-TRIS 25mg oral film-coated tablet, once None None 0 61 4 61 View
TRAM.HCl 37.5mg TRAM.HCl 37.5mg oral film-coated tablet, once None None 0 59 5 59 View
TRAM.HCl 75mg TRAM.HCl 75mg oral film-coated tablet, once None None 1 60 14 60 View
Ibuprofen 400mg Ibuprofen 400mg oral film-coated tablet, once None None 0 61 5 61 View
Placebo Placebo oral film-coated tablet, once None None 0 62 1 62 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 13.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 13.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 13.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 13.1 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDra 13.1 View