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 @ 4:40 PM
Ignite Modification Date: 2025-12-25 @ 2:29 PM
NCT ID: NCT02562066
Description: None
Frequency Threshold: 5
Time Frame: Serious adverse events (SAEs) were recorded for each patient from the time informed consent was obtained and continues through four weeks after the last dose or at the early discontinuation visit, for a total of approximately 14 weeks. Non-serious AEs were recorded for each patient after informed consent is obtained and the first administration of study drug (on Day 1 of run-in) through the last visit or at the early discontinuation visit, for a total of approximately 10 weeks .
Study: NCT02562066
Study Brief: Amifampridine Phosphate for the Treatment of Congenital Myasthenic Syndromes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Amifampridine Phosphate Treatment administered to the patient at the time of onset of the AE. Includes patients who received amifampridine phosphate during the run-in period who were not randomized for inclusion in the crossover portion of the study. 0 None 1 20 11 20 View
Placebo Treatment administered to the patient at the time of onset of the AE. 0 None 1 20 6 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Parainfluenzae virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Rhinovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ear haemorrhage SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 19.1 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 19.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Food poisoning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Paraesthesia oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Retching SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Allergy to animal SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19.1 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Anger SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Menstruation irregular SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.1 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View