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 @ 11:00 PM
Ignite Modification Date: 2025-12-25 @ 8:29 PM
NCT ID: NCT01896869
Description: AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
Frequency Threshold: 5
Time Frame: Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
Study: NCT01896869
Study Brief: FOLFIRINOX Followed by Ipilimumab With Pancreatic Tumor Vaccine in Treatment of Metastatic Pancreatic 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
Ipilimumab + Vaccine Ipilimumab and vaccine administered every 3 weeks for 4 doses, then every 8 weeks. Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3) Vaccine: 5x10\^8 cells administered in 6 intradermal injections 5 None 20 39 39 39 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
adrenal insufficiency NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
bacteremia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
catheter related infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
chest wall pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
death, disease progression NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
delerium NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
hypophysitis NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
INR increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
lung infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
malabsorption NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
neutropenia NON_SYSTEMATIC_ASSESSMENT Investigations None View
obstruction gastric NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
pneumonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
thromboembolic event - pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
weight loss NON_SYSTEMATIC_ASSESSMENT Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
abdominal distention NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
alanine aminotransferase (ALT) increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
anemia NON_SYSTEMATIC_ASSESSMENT Investigations None View
anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
ascites NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
aspartate aminotransferase (AST) increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
atelectasis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
bloating NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
bruising NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
cold intolerance NON_SYSTEMATIC_ASSESSMENT General disorders None View
colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
difficulty urinating NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
edema limbs NON_SYSTEMATIC_ASSESSMENT General disorders None View
fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
flu-like symptoms NON_SYSTEMATIC_ASSESSMENT General disorders None View
gait disturbance NON_SYSTEMATIC_ASSESSMENT General disorders None View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
hot flashes NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hyperhidrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hypophosphatemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hypophysitis NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
lymph node pain NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
lymphocyte count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
muscle cramp NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
non-cardiac pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
oral pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
pain, site of procedure/conmed NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
rhinitis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
sinus tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
thromboembolic event NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
urinary frequency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
weight loss NON_SYSTEMATIC_ASSESSMENT Investigations None View
vaccine site blisters NON_SYSTEMATIC_ASSESSMENT General disorders None View
vaccine site bruising NON_SYSTEMATIC_ASSESSMENT General disorders None View
vaccine site erythema NON_SYSTEMATIC_ASSESSMENT General disorders None View
vaccine site flares NON_SYSTEMATIC_ASSESSMENT General disorders None View
vaccine site induration NON_SYSTEMATIC_ASSESSMENT General disorders None View
vaccine site pruritus NON_SYSTEMATIC_ASSESSMENT General disorders None View
vaccine site tenderness NON_SYSTEMATIC_ASSESSMENT General disorders None View