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 @ 2:55 PM
Ignite Modification Date: 2025-12-25 @ 1:20 PM
NCT ID: NCT01430559
Description: The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Frequency Threshold: 5
Time Frame: None
Study: NCT01430559
Study Brief: Effect Of Meloxicam Versus Placebo In Mainland Chinese Patients With Osteoarthritis Of The Knee
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks. None None 2 143 0 143 View
Meloxicam 15 mg Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks. None None 0 144 0 144 View
OA Participants Not Randomized OA participants in VAS who were not randomized to placebo or meloxicam treatment. None None 0 63 0 63 View
OA Participants Randomized But Not Treated OA participants who were randomized but did not receive actual placebo or meloxicam treatment. None None 0 6 0 6 View
Healthy Participants Healthy participants who were included in validation part of the study. None None 0 52 0 52 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Haemoglobin decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View
Red blood cell count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 16.0 View
Angina unstable NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
White blood cell count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View
Other Events(If Any):