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 @ 9:40 PM
Ignite Modification Date: 2025-12-25 @ 7:22 PM
NCT ID: NCT04735432
Description: AEs will be reported by the participant (or, when appropriate, by a caregiver, surrogate, legally authorized representative). The investigator are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE and remain responsible for following up AEs that are serious, considered related to the study intervention or study procedures, or that caused the participant to discontinue the study intervention.
Frequency Threshold: 5
Time Frame: up to 12 weeks (throughout the treatment period)
Study: NCT04735432
Study Brief: Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Efgartigimod PH20 SC Patients receiving efgartigimod PH20 subcutaneous (SC) treatment efgartigimod PH20 SC: Subcutaneous injection with efgartigimod PH20 SC 0 None 8 55 37 55 View
Efgartigimod IV Patients receiving efgartigimod intravenous (IV) treatment efgartigimod IV: Intravenous infusion of efgartigimod 0 None 4 55 23 55 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Myasthenia gravis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Optic neuritis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Testicular cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Myasthenia gravis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Injection site bruising SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Injection site rash SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View