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 @ 2:46 PM
Ignite Modification Date: 2025-12-25 @ 1:14 PM
NCT ID: NCT00857259
Description: Only two arms are represented in the Serious Adverse Events and Adverse Events \> 5% Tables. The Ranibizumab 0.5 mg IVT arm is omitted because there were no SAEs or AEs reported in that treatment group.
Frequency Threshold: 5
Time Frame: None
Study: NCT00857259
Study Brief: The Efficacy of Oral Everolimus in Patients With Neovascular Age-related Macular Degeneration
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Oral Everolimus 5 mg 5 mg once daily plus sham ocular injection on Day 1 (Baseline) None None 0 8 6 8 View
Everolimus 5 mg and Ranibizumab 0.5 mg Everolimus orally 5 mg once daily plus Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline) None None 0 7 5 7 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Macular degeneration SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Optic disc haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Vitreous floaters SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Mouth ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Tongue ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Furuncle SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Periorbital haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood triglycerides increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Osteopenia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal discomfort SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Aortic wall hypertrophy SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View