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 @ 2:22 PM
Ignite Modification Date: 2025-12-25 @ 12:58 PM
NCT ID: NCT05643495
Description: Safety set included all participants who had received at least 1 dose of study drug in this study.
Frequency Threshold: 5
Time Frame: Day 1 up to Week 52
Study: NCT05643495
Study Brief: A Study to Evaluate Efficacy and Safety of VX-864 in Participants With the PiZZ Genotype
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group A VX-864 500 mg Participants received VX-864 q12h for 48 weeks or until study drug dosing was terminated. 0 None 1 10 10 10 View
Group B VX-864 500 mg Participants undergo a liver biopsy before receiving VX-864 q12h for 48 weeks or until study drug dosing was terminated and undergo a second liver biopsy at either Week 24 or Week 48. 0 None 0 4 4 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Porphyria non-acute SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 27.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Mouth ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Hypertransaminasaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Drug eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Dyshidrotic eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Photosensitivity reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Post inflammatory pigmentation change SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Pseudoporphyria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Paraesthesia oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Hyperaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 27.0 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View