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 @ 12:43 AM
Ignite Modification Date: 2025-12-25 @ 10:55 PM
NCT ID: NCT04988867
Description: None
Frequency Threshold: 5
Time Frame: Mean study drug exposure 434 days, corresponding to 1.2 years
Study: NCT04988867
Study Brief: An Open-Label Study of Trofinetide for the Treatment of Girls Two to Five Years of Age Who Have Rett Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Trofinetide Trofinetide oral solution was administered twice daily for up to approximately 26 months, orally or administered by gastrostomy (G) tube. 0 None 4 15 14 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastroenteritis sapovirus NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Altered state of consciousness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Iron deficiency anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Rett syndrome NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 24.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Salivary hypersecretion NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Ear infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Candida infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Croup infectious NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Oral candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Otitis media NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Otitis media acute NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Pharyngitis streptococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Arthropod bite NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Feeding disorder NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Scoliosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Epilepsy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Altered state of consciousness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Irritability NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Dermatitis diaper NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Excessive granulation tissue NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Viral upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View