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 @ 10:32 PM
Ignite Modification Date: 2025-12-25 @ 8:04 PM
NCT ID: NCT01675635
Description: None
Frequency Threshold: 0.0
Time Frame: The protocol requires safety follow up until 24 hours after the last study medication dosing. So the longest time one subject in the study is 48 hours after the 1st study medication doing, include taking full of the 4 times dosing(intotal 24 hours) following by safety follow up for 24 hours.
Study: NCT01675635
Study Brief: OxyNorm Capsules in Post-Operative Pain Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
OxyNorm Capsules To determine the efficacy and safety of OxyNorm Capsules. OxyNorm Capsules: dosage:5mg,l0mg and 20mg dosage form:capsule frequency:every 6h, duration:24 hours 0 None 0 117 35 117 View
Morphine Tablet To determine the efficacy and safety of Morphine tablet. Morphine tablet: dosage: 10mg and 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours. 0 None 0 117 35 117 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
backache NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
fever NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
glycosylated hemoglobin derease NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
leucocyte count increase NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
chest uncomfortable NON_SYSTEMATIC_ASSESSMENT General disorders None View
blood urea increase NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
swelling NON_SYSTEMATIC_ASSESSMENT General disorders None View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
postoperative infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
serum creatinine increase NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
alanine aminotransferase increase NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
high tension NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
muculoskeletalache NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
expectoration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
epigastric pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
aspartate aminotransferase increase NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
blood glucose increase NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View