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 @ 2:18 AM
Ignite Modification Date: 2025-12-26 @ 12:48 AM
NCT ID: NCT01902134
Description: Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
Frequency Threshold: 5
Time Frame: Study duration for patients was up to 6 weeks.
Study: NCT01902134
Study Brief: Oral Treatment for Orthopaedic Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride
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/TRAM Followed by DKP/TRAM Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses. None None 2 159 15 159 View
DKP Followed by DKP Dexketoprofen-single dose followed by Dexketoprofen-multiple doses. None None 3 161 18 161 View
TRAM Followed by TRAM Tramadol-single dose followed by Tramadol-multiple doses. None None 1 160 24 160 View
Placebo Followed by DKP/TRAM Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses. None None 1 54 9 54 View
Placebo Followed by DKP Placebo single dose followed by Dexketoprofen-multiple doses. None None 0 53 2 53 View
Placebo Followed by TRAM Placebo single dose followed by Tramadol-multiple doses. None None 0 54 5 54 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bone operation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (15.1) View
Heart valve replacement NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (15.1) View
Vascular graft NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (15.1) View
Device dislocation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (15.1) View
Face oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (15.1) View
Laryngeal oedema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (15.1) View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (15.1) View
Cardiac disorder NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (15.1) View
Periorbital oedema NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (15.1) View
Duodenal ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (15.1) View
Soft tissue infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (15.1) View
Periprosthetic fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (15.1) View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (15.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia postoperative NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (15.1) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (15.1) View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (15.1) View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (15.1) View