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 @ 2:18 AM
Ignite Modification Date: 2025-12-26 @ 12:48 AM
NCT ID: NCT00888134
Description: Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
Frequency Threshold: 5
Time Frame: Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Study: NCT00888134
Study Brief: Selumetinib in Cancers With BRAF Mutations
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment (Selumetinib) Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Selumetinib: Given PO None None 17 28 28 28 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders NCI CTCAE V 3.0 View
SGPT SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE V 3.0 View
Fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE V 3.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE V 3.0 View
pulmonary / URT infection SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE V 3.0 View
malignant ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE V 3.0 View
ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE V 3.0 View
SGOT SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE V 3.0 View
confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders NCI CTCAE V 3.0 View
fatigue SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE V 3.0 View
mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders NCI CTCAE V 3.0 View
fatal progressive disease SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) NCI CTCAE V 3.0 View
dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE V 3.0 View
increased intraocular pressure SYSTEMATIC_ASSESSMENT Eye disorders NCI CTCAE V 3.0 View
dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE V 3.0 View
blurry vision SYSTEMATIC_ASSESSMENT Eye disorders NCI CTCAE V 3.0 View
skin infection SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE V 3.0 View
joint pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE V 3.0 View
muscle pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE V 3.0 View
hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE V 3.0 View
retinopathy SYSTEMATIC_ASSESSMENT Eye disorders NCI CTCAE V 3.0 View
dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE V 3.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
fever (without neutropenia) SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE V 3.0 View
lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE V 3.0 View
platelets SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE V 3.0 View
hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTCAE V 3.0 View
INR SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE V 3.0 View
PTT SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE V 3.0 View
fatigue SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE V 3.0 View
insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders NCI CTCAE V 3.0 View
dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE V 3.0 View
nail changes SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE V 3.0 View
pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE V 3.0 View
rash/desquamation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE V 3.0 View
rash: acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE V 3.0 View
rash: erythema multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE V 3.0 View
skin - other SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE V 3.0 View
anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE V 3.0 View
constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE V 3.0 View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE V 3.0 View
dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE V 3.0 View
fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE V 3.0 View
mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE V 3.0 View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE V 3.0 View
taste disturbance SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE V 3.0 View
vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE V 3.0 View
hemorrhage - anus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE V 3.0 View
hemorrhage - nose SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE V 3.0 View
edema - head and neck SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE V 3.0 View
edema - limb SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE V 3.0 View
edema - trunk SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE V 3.0 View
hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE V 3.0 View
alkaline phosphatase SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE V 3.0 View
SGPT SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE V 3.0 View
SGOT SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE V 3.0 View
bicarbonate SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE V 3.0 View
bilirubin SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE V 3.0 View
hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE V 3.0 View
hypercholesterolemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE V 3.0 View
creatinine SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE V 3.0 View
hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE V 3.0 View
hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE V 3.0 View
hypermagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE V 3.0 View
hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE V 3.0 View
hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE V 3.0 View
hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE V 3.0 View
hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE V 3.0 View
hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE V 3.0 View
dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE V 3.0 View
depression SYSTEMATIC_ASSESSMENT Psychiatric disorders NCI CTCAE V 3.0 View
neuropathy - sensory SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE V 3.0 View
tearing SYSTEMATIC_ASSESSMENT Eye disorders NCI CTCAE V 3.0 View
abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE V 3.0 View
back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE V 3.0 View
extremity - limb pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE V 3.0 View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE V 3.0 View
joint pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE V 3.0 View
cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE V 3.0 View
dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE V 3.0 View
voice changes/ dysarthria SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE V 3.0 View
infection SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE V 3.0 View
other SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE V 3.0 View
other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE V 3.0 View
other SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE V 3.0 View
other SYSTEMATIC_ASSESSMENT Eye disorders NCI CTCAE V 3.0 View
other SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE V 3.0 View
allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE V 3.0 View
tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders NCI CTCAE V 3.0 View
hemoglobin - low SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE V 3.0 View
leukocytes SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE V 3.0 View