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: 2025-12-25 @ 4:36 AM
Ignite Modification Date: 2025-12-26 @ 3:38 AM
NCT ID: NCT02836418
Description: Safety population was defined as all participants who received at least 1 full or partial dose of ATYR1940 in the current study (Study ATYR1940-C-006) and had a post-infusion safety observation since enrollment in parent studies. Mortality, Serious Adverse Event, and Other Adverse Event data were prespecified to be collected as a single Arm/Group for any participant who received at least 1 dose of the study drug, regardless of their dose level.
Frequency Threshold: 0
Time Frame: Baseline up to approximately Week 39
Study: NCT02836418
Study Brief: Study to Evaluate the Long-Term Safety, Tolerability, and Biological Activity of ATYR1940 in Participants With Limb Girdle and Facioscapulohumeral Muscular Dystrophy (FSHD)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ATYR1940 Participants received ATYR1940 up to 3.0 mg/kg IV infusion once weekly until approval of ATYR1940, discontinuation of its development, the study was closed by the Sponsor, or a criterion for study drug discontinuation was met (up to a maximum of 34 weeks). 0 None 0 8 7 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Bone contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Laryngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Blood bicarbonate decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
ECG signs of ventricular hypertrophy NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Electrocardiogram P wave biphasic NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Burning sensation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Tension headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Atrioventricular block first degree NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Right atrial dilatation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Ovarian cyst NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 18.1 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Arthropathy NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Muscular weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Musculoskeletal chest pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Musculoskeletal stiffness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Cyst NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Infusion site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Back injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View