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 @ 5:29 PM
Ignite Modification Date: 2025-12-25 @ 3:03 PM
NCT ID: NCT01365468
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01365468
Study Brief: Efficacy and Safety of RAD001 in Treating Plexiform Neurofibromas (PN) Associated With Neurofibromatosis (NF1)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Stratum 1 Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity with documented progressive PN prior to study entry wereenrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily. None None 1 4 4 4 View
Stratum 2 Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity that do not have documented progression of the PN at the time of study entry were enrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily. None None 0 5 5 5 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
External ear inflammation SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Ocular hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Mouth ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tendonitis 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 triglycerides increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Drug level increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Eosinophil count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Fibroma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Tic SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Breast mass SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Metrorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Vaginal haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Cytoreductive surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Tooth extraction SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Low density lipoprotein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pharyngeal erythema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View