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 @ 1:07 AM
Ignite Modification Date: 2025-12-25 @ 11:19 PM
NCT ID: NCT04115293
Description: A TEAE is defined as an AE starting on or after the time of first administration of IMP and up to and including 40 days after the final dose (or last contact depending on which occurs first). Adverse events starting before the date of the first administration of IMP were not considered TEAEs.
Frequency Threshold: 5
Time Frame: From Baseline (Day 1) to Safety follow-up visit (19 Weeks [12 weeks Treatment Period plus up to 7 weeks follow-up])
Study: NCT04115293
Study Brief: Safety, Tolerability, and Efficacy of Zilucoplan in Subjects 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
Placebo Participants self-administered zilucoplan (RA101495) matching placebo as subcutaneous (SC) injection during 12-week Treatment Period. 1 None 13 88 34 88 View
Zilucoplan 0.3 mg/kg Participants self-administered zilucoplan (RA101495) 0.3 milligrams/kilogram/day (mg/kg/day) SC injection during 12-week Treatment Period. 1 None 11 86 41 86 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Aphthous ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Oesophageal candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Oral candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
COVID-19 pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Herpes simplex meningoencephalitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Lipase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Metastases to meninges NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24 View
Basal cell carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24 View
Cerebral haemorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
Cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
Myasthenia gravis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
Hyperemesis gravidarum NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 24 View
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Angioedema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Injection site bruising NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Injection site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24 View
Lipase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Amylase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
Myasthenia gravis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24 View