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 Make This Study a Gene Therapy Make This Study a Not Gene Therapy 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 @ 5:09 PM
Ignite Modification Date: 2025-12-25 @ 2:47 PM
NCT ID: NCT02208050
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data was collected for each participant for the study period (22 weeks).
Study: NCT02208050
Study Brief: A Study of the Effectiveness of Fampridine in Improving Upper Limb Function in MS
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fampridine Adverse events reported by the patients when treated with Fampridine 0 None 0 64 32 64 View
Placebo Adverse events reported by the patients when treated with placebo. 0 None 0 64 25 64 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Peripheral venous disease SYSTEMATIC_ASSESSMENT Vascular disorders MeDRA 10.0 View
Elevated hepatic enzymes SYSTEMATIC_ASSESSMENT Investigations MeDRA 10.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MeDRA 10.0 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MeDRA 10.0 View
Thrombocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MeDRA 10.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MeDRA 10.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MeDRA 10.0 View
Worsening hemiparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MeDRA 10.0 View
Muscle Spasticity SYSTEMATIC_ASSESSMENT Nervous system disorders MeDRA 10.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MeDRA 10.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MeDRA 10.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MeDRA 10.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MeDRA 10.0 View
Insomnia SYSTEMATIC_ASSESSMENT General disorders MeDRA 10.0 View
Weakness SYSTEMATIC_ASSESSMENT General disorders MeDRA 10.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MeDRA 10.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MeDRA 10.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MeDRA 10.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MeDRA 10.0 View
Muscular pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MeDRA 10.0 View
Pain extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MeDRA 10.0 View
Hip Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MeDRA 10.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 10.0 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 10.0 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 10.0 View
Lower Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 10.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 10.0 View
Laceration to Foot SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MeDRA 10.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MeDRA 10.0 View
Numbness SYSTEMATIC_ASSESSMENT Nervous system disorders MeDRA 10.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MeDRA 10.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MeDRA 10.0 View
Mobility SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MeDRA 10.0 View
Ear Infection SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 10.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 10.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 10.0 View