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 @ 11:40 PM
Ignite Modification Date: 2025-12-25 @ 9:31 PM
NCT ID: NCT01158651
Description: None
Frequency Threshold: 5
Time Frame: 1 year
Study: NCT01158651
Study Brief: Everolimus for Children With NF1 Chemotherapy-Refractory Radiographic Progressive Low Grade Gliomas
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
RAD001 (Everolimus) Active Therapy If you take part in this research study, you will be given a participant diary for each treatment course to help you keep track of when you take your RAD001. You will be required to bring the completed diary at each scheduled visit. A treatment "course" lasts 4 weeks and there will not be any breaks between courses. You may stay on study for a total of 12 courses (48 weeks). You will take the study medication (tablets) by mouth, once a day during each course for as long as you are participating in this study. You will also be required to take an antibiotic during treatment to prevent infection. If you take part in this research study, you will be given a participant diary for each treatment course to help you keep track of when you take your RAD001. You will be required to bring the completed diary at each scheduled visit. A treatment "course" lasts 4 weeks and there will not be any breaks between courses. You may stay on study for a total of 12 courses (48 weeks). 1 None 6 23 21 23 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cardio Respiratory Arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diabetes insipidus NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Electrolyte disturbance NON_SYSTEMATIC_ASSESSMENT Investigations None View
Hydrocephalus NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypernatremia NON_SYSTEMATIC_ASSESSMENT Investigations None View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Investigations None View
Infection with absolute neutrophil count (ANC) NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Low hemoglobin NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pelvic Mass NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Shunt Malfunction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Resection of right temporal lobe tumor NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Blindness NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
brain surgery NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Brain resection NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Other non-hematologic toxicity NON_SYSTEMATIC_ASSESSMENT Investigations None View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hyperlipidemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypertriglyceridemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Mucositis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View