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 @ 6:54 PM
Ignite Modification Date: 2025-12-25 @ 4:27 PM
NCT ID: NCT01338857
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01338857
Study Brief: Sorafenib in Children and Young Adults With Recurrent or Progressive Low-Grade Astrocytomas
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sorafenib (Nexavar) Sorafenib will be administered orally BID (approximately every 12 hours). A cycle is 28 days w/o interruption between cycles. Patients may receive up to a total of 12 cycles provided that no off-protocol or off-study criteria are met. Children/adolescents (\< 18 years of age, non-NF1): 200 mg/m2/dose PO twice daily (rounded to the nearest 50 mg increment) to a maximum of 400 mg PO twice daily Adults (greater than or equal to 18 years of age, non-NF1): 400 mg PO twice daily NF1 patients: 80mg/m2/dose PO 2x daily to max of 150mg PO 2x daily. None None 0 12 12 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ALT increase None Investigations None View
anal hemorrhage None Gastrointestinal disorders None View
anemia None Blood and lymphatic system disorders None View
anorexia None Metabolism and nutrition disorders None View
ascites None Gastrointestinal disorders None View
AST elevation None Investigations None View
blood in stool None Gastrointestinal disorders None View
cold symptoms (runny nose) None Respiratory, thoracic and mediastinal disorders None View
conjunctivitis None Eye disorders None View
constipation None Gastrointestinal disorders None View
cough None Respiratory, thoracic and mediastinal disorders None View
decreased appetite None Metabolism and nutrition disorders None View
diarrhea None Gastrointestinal disorders None View
dry skin None Skin and subcutaneous tissue disorders None View
emesis None Gastrointestinal disorders None View
epistaxis None Respiratory, thoracic and mediastinal disorders None View
erythema None Skin and subcutaneous tissue disorders None View
eye pain None Eye disorders None View
fatigue None General disorders None View
fever None General disorders None View
flushing (facial) None Vascular disorders None View
gastric hemorrhage None Gastrointestinal disorders None View
GGT None Investigations None View
hand-foot skin reaction None Skin and subcutaneous tissue disorders None View
headache None Nervous system disorders None View
hyperglycemia None Metabolism and nutrition disorders None View
hyperkeratotic eruptions None Skin and subcutaneous tissue disorders None View
hypernatremia None Metabolism and nutrition disorders None View
hyperpigmentation None Skin and subcutaneous tissue disorders None View
hypertension None Vascular disorders None View
hypocalcemia None Metabolism and nutrition disorders None View
hypoglycemia None Metabolism and nutrition disorders None View
hypokalemia None Metabolism and nutrition disorders None View
hyponatremia None Metabolism and nutrition disorders None View
hypophosphatemia None Metabolism and nutrition disorders None View
hypopigmentation None Skin and subcutaneous tissue disorders None View
hypotension None Vascular disorders None View
intracranial pressure None Nervous system disorders None View
lethargy None Nervous system disorders None View
lymphocyte count decreased None Investigations None View
lymphopenia None Investigations None View
mucositis None Respiratory, thoracic and mediastinal disorders None View
muscle weakness-right sided None Musculoskeletal and connective tissue disorders None View
nausea None Gastrointestinal disorders None View
neutrophil count decreased None Investigations None View
papulopustular rash None Skin and subcutaneous tissue disorders None View
platelet count decreased None Investigations None View
postnasal drip None Respiratory, thoracic and mediastinal disorders None View
pruritus None Skin and subcutaneous tissue disorders None View
ptosis (CN III) None Eye disorders None View
PTT None Investigations None View
rash None Skin and subcutaneous tissue disorders None View
respiratory failure None Respiratory, thoracic and mediastinal disorders None View
skin hyperpigmentation None Skin and subcutaneous tissue disorders None View
skin hypopigmentation None Skin and subcutaneous tissue disorders None View
skin ulceration (nasal) None Skin and subcutaneous tissue disorders None View
sore throat None Respiratory, thoracic and mediastinal disorders None View
tooth pain None Gastrointestinal disorders None View
upper respiratory infection None Respiratory, thoracic and mediastinal disorders None View
UTI None Infections and infestations None View
vascular access complication None Injury, poisoning and procedural complications None View
voice alteration None Respiratory, thoracic and mediastinal disorders None View
vomiting None Gastrointestinal disorders None View
watery and itchy eyes None Eye disorders None View
white blood cell decreased None Investigations None View