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 @ 10:19 PM

Ignite Modification Date: 2025-12-25 @ 7:52 PM

NCT ID: NCT00948935

Description: None

Frequency Threshold: 0

Time Frame: None

Study: NCT00948935

Study Brief: Study of Gemcitabine, Irinotecan and Panitumumab in Patients With Advanced and Metastatic Biliary Tract Adenocarcinoma

Event Groups(If Any):

Event Groups

Title	Description	Deaths # Affected	Deaths # At Risk	Serious # Affected	Serious # At Risk	Other # Affected	Other # At Risk	View

Chemotherapy	Gemcitabine (Days 1, 8), irinotecan (days 1, 8) and panitumumab (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities. Gemcitabine, Irinotecan, Panitumumab: Gemcitabine 1000 mg/m2 over 100 minutes(Days 1, 8), irinotecan 100 mg/m2 IV over 60 minutes(days 1, 8) and panitumumab 9 mg/kg IV (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.	None	None	21	35	35	35	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

Cardiac Arrhythmia	None	Cardiac disorders	None	View
Fatigue	None	General disorders	None	View
Fever	None	General disorders	None	View
Respiratory Arrest	None	Respiratory, thoracic and mediastinal disorders	None	View
Rash	None	Skin and subcutaneous tissue disorders	None	View
Dehydration	None	Gastrointestinal disorders	None	View
Diarrhea	None	Gastrointestinal disorders	None	View
Free Air	None	Gastrointestinal disorders	None	View
Obstruction, GI	None	Gastrointestinal disorders	None	View
Abdomen NOS	None	Infections and infestations	None	View
Febrile Neutropenia	None	Infections and infestations	None	View
Neurological Meningitis	None	Infections and infestations	None	View
Sepsis	None	Infections and infestations	None	View
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e	None	Infections and infestations	None	View
Infection with normal ANC or Grade 1 or 2 neutrophils	None	Infections and infestations	None	View
Infection with unknown ANC	None	Infections and infestations	None	View
Hyperbilirubinemia	None	Metabolism and nutrition disorders	None	View
Hypercalcemia	None	Metabolism and nutrition disorders	None	View
Hypomagnesemia	None	Metabolism and nutrition disorders	None	View
Confusion	None	Nervous system disorders	None	View
Encephalopathy	None	Nervous system disorders	None	View
Syncope (fainting)	None	Nervous system disorders	None	View
Pain	None	General disorders	None	View
Dyspnea	None	Respiratory, thoracic and mediastinal disorders	None	View
chronic obstructive pulmonary disease	None	Reproductive system and breast disorders	None	View
Pleural Effusion	None	Respiratory, thoracic and mediastinal disorders	None	View
Renal Failure	None	Renal and urinary disorders	None	View
Peripheral arterial ischemia	None	Vascular disorders	None	View
Thrombosis/thombus/embolism	None	Vascular disorders	None	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

fungal infection	None	Infections and infestations	None	View
aches	None	General disorders	None	View
hypergylcemia	None	Metabolism and nutrition disorders	None	View
hypoglymcemia	None	Metabolism and nutrition disorders	None	View
carpal tunel	None	Musculoskeletal and connective tissue disorders	None	View
hand tremors	None	Nervous system disorders	None	View
itching	None	Skin and subcutaneous tissue disorders	None	View
IV infiltration	None	Skin and subcutaneous tissue disorders	None	View
karatoses	None	Skin and subcutaneous tissue disorders	None	View
kidney stone	None	Renal and urinary disorders	None	View
hypermagnesemia	None	Metabolism and nutrition disorders	None	View
mouth sores	None	Gastrointestinal disorders	None	View
mucositis	None	Gastrointestinal disorders	None	View
bloating	None	Gastrointestinal disorders	None	View
abdominal cramping	None	Gastrointestinal disorders	None	View
abdominal fullness	None	Gastrointestinal disorders	None	View
abdominal pain	None	Gastrointestinal disorders	None	View
acidosis	None	Metabolism and nutrition disorders	None	View
acne-form	None	Skin and subcutaneous tissue disorders	None	View
acute arterial occulsion LLE	None	Vascular disorders	None	View
infusion reaction	None	General disorders	None	View
acute renal failure	None	Renal and urinary disorders	None	View
Hypoalbuminemia	None	Metabolism and nutrition disorders	None	View
alkaline phosphatase (high)	None	Metabolism and nutrition disorders	None	View
alkalosis	None	Metabolism and nutrition disorders	None	View
allergic rhinitis	None	Immune system disorders	None	View
tape allergy	None	Immune system disorders	None	View
alopecia	None	Skin and subcutaneous tissue disorders	None	View
Alanine Aminotransferase (high)	None	Metabolism and nutrition disorders	None	View
amylase (high)	None	Metabolism and nutrition disorders	None	View
back pain	None	Musculoskeletal and connective tissue disorders	None	View
belching	None	Gastrointestinal disorders	None	View
Metabolic Acidosis	None	Metabolism and nutrition disorders	None	View
bilirubin (high)	None	Metabolism and nutrition disorders	None	View
hemorrhoids	None	Vascular disorders	None	View
dermal changes	None	Blood and lymphatic system disorders	None	View
diarrhea	None	Gastrointestinal disorders	None	View
dizziness	None	General disorders	None	View
dry cough	None	Respiratory, thoracic and mediastinal disorders	None	View
dry eye	None	Eye disorders	None	View
dry mouth	None	Gastrointestinal disorders	None	View
dry skin	None	Skin and subcutaneous tissue disorders	None	View
dyspnea	None	Respiratory, thoracic and mediastinal disorders	None	View
Dysgeusia	None	Gastrointestinal disorders	None	View
Dyspepsia	None	Gastrointestinal disorders	None	View
dysphagia	None	Gastrointestinal disorders	None	View
electrolyte imbalance	None	Metabolism and nutrition disorders	None	View
elevated LTF	None	Metabolism and nutrition disorders	None	View
epistaxis	None	Respiratory, thoracic and mediastinal disorders	None	View
erectile dysfunction	None	Reproductive system and breast disorders	None	View
Palmar-plantar erythrodysesthesia syndrome	None	Skin and subcutaneous tissue disorders	None	View
headache	None	Nervous system disorders	None	View
heartburn	None	Gastrointestinal disorders	None	View
hematuria	None	Renal and urinary disorders	None	View
anemia	None	Blood and lymphatic system disorders	None	View
Hepatic Encephalopathy	None	Hepatobiliary disorders	None	View
herituism	None	Skin and subcutaneous tissue disorders	None	View
hiccups	None	Respiratory, thoracic and mediastinal disorders	None	View
hoarseness	None	Respiratory, thoracic and mediastinal disorders	None	View
hot flashes	None	Vascular disorders	None	View
Hyperesthesia	None	Musculoskeletal and connective tissue disorders	None	View
hypertension	None	Vascular disorders	None	View
hypertochosis	None	Skin and subcutaneous tissue disorders	None	View
hypokalemia	None	Metabolism and nutrition disorders	None	View
Hypomagnesemia	None	Metabolism and nutrition disorders	None	View
hypoxia	None	Respiratory, thoracic and mediastinal disorders	None	View
skin infection	None	Infections and infestations	None	View
sinus infection	None	Infections and infestations	None	View
finger infection	None	Infections and infestations	None	View
insomnia	None	Psychiatric disorders	None	View
toe infection	None	Infections and infestations	None	View
leg cramps	None	Musculoskeletal and connective tissue disorders	None	View
leg ulceration	None	Skin and subcutaneous tissue disorders	None	View
Leukocytosis	None	Blood and lymphatic system disorders	None	View
light headedness	None	Nervous system disorders	None	View
loss of appetite	None	Metabolism and nutrition disorders	None	View
lymphopenia	None	Investigations	None	View
muscle cramping	None	Musculoskeletal and connective tissue disorders	None	View
nausea	None	Gastrointestinal disorders	None	View
neutropenic fever	None	Blood and lymphatic system disorders	None	View
Neutrophil count decreased	None	Investigations	None	View
night sweats	None	General disorders	None	View
numbness	None	Nervous system disorders	None	View
oral thrush	None	Infections and infestations	None	View
occular infection	None	Infections and infestations	None	View
hypertrichosis	None	Skin and subcutaneous tissue disorders	None	View
periorbital hair changes	None	Skin and subcutaneous tissue disorders	None	View
xerosis back	None	Skin and subcutaneous tissue disorders	None	View
buttock pain	None	Musculoskeletal and connective tissue disorders	None	View
chest pain	None	General disorders	None	View
Hepatic pain	None	Hepatobiliary disorders	None	View
Joint Pain	None	Musculoskeletal and connective tissue disorders	None	View
Ear Pain	None	Ear and labyrinth disorders	None	View
shoulder pain	None	Musculoskeletal and connective tissue disorders	None	View
Solar Plexis Pain	None	Nervous system disorders	None	View
forearm pain	None	Musculoskeletal and connective tissue disorders	None	View
Upper Quadrant Pain	None	Musculoskeletal and connective tissue disorders	None	View
Scapula pain	None	Musculoskeletal and connective tissue disorders	None	View
stent pain	None	Injury, poisoning and procedural complications	None	View
palpitations	None	Cardiac disorders	None	View
paronychia	None	Infections and infestations	None	View
Pulmonary Embolism	None	Vascular disorders	None	View
Pericardial effusion	None	Cardiac disorders	None	View
Hypophosphatemia	None	Metabolism and nutrition disorders	None	View
Platelet count decreased	None	Investigations	None	View
Pleural effusion	None	Reproductive system and breast disorders	None	View
pneumonia	None	Infections and infestations	None	View
poison ivy	None	Skin and subcutaneous tissue disorders	None	View
Hypokalemia	None	Metabolism and nutrition disorders	None	View
Pruritis	None	Skin and subcutaneous tissue disorders	None	View
Activated partial thromboplastin time prolonged	None	Investigations	None	View
rash	None	Skin and subcutaneous tissue disorders	None	View
rectal bleeding	None	Renal and urinary disorders	None	View
rectal fissure	None	Renal and urinary disorders	None	View
reflux	None	Gastrointestinal disorders	None	View
renal failure	None	Renal and urinary disorders	None	View
respiratory infection	None	Infections and infestations	None	View
rhinitis	None	Immune system disorders	None	View
rigors	None	General disorders	None	View
scratched cornea	None	Eye disorders	None	View
seasonal allergy	None	Immune system disorders	None	View
sepsis	None	Infections and infestations	None	View
septic shock	None	Infections and infestations	None	View
shortness of breath	None	Respiratory, thoracic and mediastinal disorders	None	View
sinus headache	None	Nervous system disorders	None	View
sinus tachcardia	None	Vascular disorders	None	View
sinusitus	None	Infections and infestations	None	View
small bowel obstruction	None	Gastrointestinal disorders	None	View
Hypernatremia	None	Metabolism and nutrition disorders	None	View
Hyponatremia	None	Metabolism and nutrition disorders	None	View
somnolence	None	Nervous system disorders	None	View
sore throat	None	Respiratory, thoracic and mediastinal disorders	None	View
sweating	None	General disorders	None	View
syncope	None	Nervous system disorders	None	View
taste alteration	None	Gastrointestinal disorders	None	View
deep vein thrombosis	None	Vascular disorders	None	View
thrombocytosis	None	Blood and lymphatic system disorders	None	View
thrombosis	None	Vascular disorders	None	View
thrush	None	Infections and infestations	None	View
trichomegaly	None	Skin and subcutaneous tissue disorders	None	View
Hypertriglyceridemia	None	Metabolism and nutrition disorders	None	View
upper respiratory congestion	None	Respiratory, thoracic and mediastinal disorders	None	View
upset stomach	None	Gastrointestinal disorders	None	View
urinary tract infection	None	Infections and infestations	None	View
vessel injury	None	Injury, poisoning and procedural complications	None	View
vomiting	None	Gastrointestinal disorders	None	View
weight loss	None	Investigations	None	View
yeast infection	None	Infections and infestations	None	View
Hyperkalemia	None	Metabolism and nutrition disorders	None	View
exostosis	None	Skin and subcutaneous tissue disorders	None	View
eye infection	None	Infections and infestations	None	View
neutropenia	None	Blood and lymphatic system disorders	None	View
anorexia	None	Gastrointestinal disorders	None	View
anxiety	None	Psychiatric disorders	None	View
ascending cholangitis	None	Infections and infestations	None	View
ascites	None	Gastrointestinal disorders	None	View
Aspartate Aminotransferase (high)	None	Metabolism and nutrition disorders	None	View
atelectasis	None	Respiratory, thoracic and mediastinal disorders	None	View
edema	None	Blood and lymphatic system disorders	None	View
blurred vision	None	Eye disorders	None	View
Body Aches	None	Musculoskeletal and connective tissue disorders	None	View
low calcium	None	Metabolism and nutrition disorders	None	View
high calcium	None	Metabolism and nutrition disorders	None	View
cellulitis	None	Infections and infestations	None	View
cerebro-vascular ischemia	None	Nervous system disorders	None	View
cheliosis	None	Skin and subcutaneous tissue disorders	None	View
Chills	None	General disorders	None	View
cold (respiratory)	None	Immune system disorders	None	View
confusion	None	Psychiatric disorders	None	View
congestion	None	Respiratory, thoracic and mediastinal disorders	None	View
conjuctivitis	None	Infections and infestations	None	View
constipation	None	Gastrointestinal disorders	None	View
contact dermatitis	None	Skin and subcutaneous tissue disorders	None	View
cough	None	Respiratory, thoracic and mediastinal disorders	None	View
high creatinine	None	Metabolism and nutrition disorders	None	View
decreased appetite	None	Gastrointestinal disorders	None	View
dehydration	None	Gastrointestinal disorders	None	View
dementia	None	Psychiatric disorders	None	View
depression	None	Psychiatric disorders	None	View
fall	None	Injury, poisoning and procedural complications	None	View
fatigue	None	General disorders	None	View
febrile neutropenia	None	Infections and infestations	None	View
Fever	None	General disorders	None	View
flatulance	None	Gastrointestinal disorders	None	View
floater	None	Eye disorders	None	View
flu-like symptoms	None	General disorders	None	View
Flush	None	Vascular disorders	None	View
Foot pain	None	Musculoskeletal and connective tissue disorders	None	View
fracture	None	Musculoskeletal and connective tissue disorders	None	View