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 @ 5:03 AM
Ignite Modification Date: 2025-12-26 @ 4:05 AM
NCT ID: NCT01227018
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01227018
Study Brief: PhII Study STA-9090 as Second or Third-Line Therapy for Metastatic Pancreas Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
STA-9090 175 mg/m2 STA-9090 IV over 1 hour once a week for 3 weeks, followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression. None None 9 14 13 14 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain None Gastrointestinal disorders None View
alanine aminotransferase increased None Investigations None View
alkaline phosphatase increased None Investigations None View
ascites None Gastrointestinal disorders None View
aspartate aminotransferase increased None Investigations None View
biliary tract infection-cholangitis None Hepatobiliary disorders None View
chills None General disorders None View
confusion None Psychiatric disorders None View
dehydration None Metabolism and nutrition disorders None View
dyspnea None Reproductive system and breast disorders None View
failure to thrive None General disorders None View
gastric perforation None Gastrointestinal disorders None View
hepatic failure None Hepatobiliary disorders None View
hyperkalemia None Metabolism and nutrition disorders None View
acute kidney injury None Renal and urinary disorders None View
blood bilirubin increased None Hepatobiliary disorders None View
hypokalemia None Metabolism and nutrition disorders None View
hyponatremia None Metabolism and nutrition disorders None View
lung infection None Respiratory, thoracic and mediastinal disorders None View
malaise None General disorders None View
nausea None Gastrointestinal disorders None View
pleural effusion None Respiratory, thoracic and mediastinal disorders None View
renal calculi None Renal and urinary disorders None View
thromboembolic event None Vascular disorders None View
urinary tract infection None Renal and urinary disorders None View
vomiting None Gastrointestinal disorders None View
Acute respiratory failure None Respiratory, thoracic and mediastinal disorders None View
hypotension None Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
diarrhea None Gastrointestinal disorders None View
constipation None Gastrointestinal disorders None View
nausea None Gastrointestinal disorders None View
vomiting None Gastrointestinal disorders None View
flatulence None Gastrointestinal disorders None View
gastrointestinal disorders-other None Gastrointestinal disorders None View
lymphocyte count decreased None Blood and lymphatic system disorders None View
weight loss None Metabolism and nutrition disorders None View
creatinine increased None Investigations None View
fatigue None General disorders None View
edema limbs None General disorders None View
pain None General disorders None View
chills None General disorders None View
edema face None General disorders None View
general disorders-other None General disorders None View
anemia None Blood and lymphatic system disorders None View
blood and lymphatic system disorders-other None Blood and lymphatic system disorders None View
dysgeusia None Nervous system disorders None View
headache None Nervous system disorders None View
dizziness None Nervous system disorders None View
nervous system disorders-other None Nervous system disorders None View
paresthesia None Nervous system disorders None View
peripheral sensory neuropathy None Nervous system disorders None View
tremor None Nervous system disorders None View
hypotension None Vascular disorders None View
lung infection None Respiratory, thoracic and mediastinal disorders None View
irritability None General disorders None View
ascites None Gastrointestinal disorders None View
bloating None Gastrointestinal disorders None View
dyspepsia None Gastrointestinal disorders None View
esophageal pain None Gastrointestinal disorders None View
hemorrhoids None Gastrointestinal disorders None View
rectal hemorrhage None Gastrointestinal disorders None View
hyponatremia None Metabolism and nutrition disorders None View
hypokalemia None Metabolism and nutrition disorders None View
anorexia None Metabolism and nutrition disorders None View
dehydration None Metabolism and nutrition disorders None View
hyperglycemia None Metabolism and nutrition disorders None View
hypoalbuminemia None Metabolism and nutrition disorders None View
hypocalcemia None Metabolism and nutrition disorders None View
hyperkalemia None Metabolism and nutrition disorders None View
hypomagnesemia None Metabolism and nutrition disorders None View
metabolism and nutrition disorders-other None Metabolism and nutrition disorders None View
alkaline phosphatase increased None Investigations None View
alanine aminotransferase increased None Investigations None View
aspartate aminotransferase increased None Investigations None View
blood bilirubin increased None Hepatobiliary disorders None View
platelet count decreased None Blood and lymphatic system disorders None View
depression None Psychiatric disorders None View
insomnia None Psychiatric disorders None View
confusion None Psychiatric disorders None View
psychosis None Psychiatric disorders None View
dyspnea None Respiratory, thoracic and mediastinal disorders None View
hoarseness None Respiratory, thoracic and mediastinal disorders None View
laryngeal inflammation None Respiratory, thoracic and mediastinal disorders None View
sleep apnea None Respiratory, thoracic and mediastinal disorders None View
back pain None Musculoskeletal and connective tissue disorders None View
musculoskeletal and connective tissue disorder-other None Musculoskeletal and connective tissue disorders None View
pain-extremity None Musculoskeletal and connective tissue disorders None View
cardiac disorder-other None Cardiac disorders None View
sinus bradycardia None Cardiac disorders None View
sinus tachycardia None Cardiac disorders None View
bruising None Injury, poisoning and procedural complications None View
fall None Injury, poisoning and procedural complications None View
renal and urinary disorder-other None Renal and urinary disorders None View
urinary frequency None Renal and urinary disorders None View
dry skin None Skin and subcutaneous tissue disorders None View
rash maculo-papular None Skin and subcutaneous tissue disorders None View
abdominal pain None Gastrointestinal disorders None View