Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search All Studies All Organizations Report Bug
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 @ 5:56 PM
Ignite Modification Date: 2025-12-24 @ 5:56 PM
NCT ID: NCT01618968
Description: Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
Frequency Threshold: 2
Time Frame: The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 49 subjects.
Study: NCT01618968
Study Brief: Comparison of Methotrexate (MTX) and the VIBEX™ MTX Device
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
10mg MTX \[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\] None None 0 13 2 13 View
15mg MTX \[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\] None None 1 12 0 12 View
20mg MTX \[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\] None None 0 12 1 12 View
25mg MTX \[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\] None None 1 12 0 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Sick Sinus Syndrome (15 mg Vibex MTX SC Thigh) SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Myocardial Infarction (25 mg Vibex MTX SC Abdomen) SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea (20 mg MTX Oral) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Fatigue (10 mg Vibex MTX SC Thigh) SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Rheumatoid Arthritis (10 mg Vibex MTX SC Abdomen) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View