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 @ 8:02 PM
Ignite Modification Date: 2025-12-25 @ 5:35 PM
NCT ID: NCT04382404
Description: None
Frequency Threshold: 5
Time Frame: 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
Study: NCT04382404
Study Brief: Treatment of Chronic Hepatitis C During Pregnancy With Sofosbuvir/Velpatasvir
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sofosbuvir-Velpatasvir - Maternal Participants One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks 0 None 3 11 11 11 View
Sofosbuvir-Velpatasvir - Infant Participants Infants born to mothers that took one oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks during pregnancy 0 None 5 11 11 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Renal calculi NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cryptorchidism NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Respiratory distress NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Positive toxicology screen NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cholelithiasis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute Pyelonephritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Clubfoot NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Hyperbilirubinemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Transient tachypnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hemorrhage, postpartum NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Sciatica NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cholelithiasis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dental abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dermatitis, contact NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dry mouth NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fetal growth restriction NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Fluid overload, postpartum NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypertension, gestational NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Group B Streptococcus NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Heartburn NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Opioid withdrawal NON_SYSTEMATIC_ASSESSMENT General disorders None View
Preeclampsia NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Pyelonephritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rectal bleeding NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Thrombophlebitis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vaginal bleeding NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Weight gain NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Otitis media NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Atopic dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hyperbilirubinemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Jaundice NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Weight loss NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Vision screen, abnormal NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Croup NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dacrocystitis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Diaper dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Eye nystagmus NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
Gross motor scores borderline to below average NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hand, foot and mouth disease NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nursemaid's elbow NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nasolacrimal duct obstruction NON_SYSTEMATIC_ASSESSMENT General disorders None View
Oral thrush NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Orolabial Herpes Simplex Virus NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Respiratory Syncytial Virus NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Roseola NON_SYSTEMATIC_ASSESSMENT General disorders None View
Seborrhea of scalp NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sickle cell trait NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Temperature instability NON_SYSTEMATIC_ASSESSMENT General disorders None View
Tibial torsion of lower legs NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Urogenital candidiasis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View