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 @ 2:16 AM
Ignite Modification Date: 2025-12-26 @ 12:46 AM
NCT ID: NCT00305760
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00305760
Study Brief: Vaccine Therapy, Cyclophosphamide, and Cetuximab in Treating Patients With Metastatic or Locally Advanced 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
Cyclophosphamide, Pancreatic Tumor Vaccine, Cetuximab Cetuximab: Cetuximab will be administered at an initial dose of 400 mg/m2, followed by weekly doses of 250 mg/m2 for a total of 6 cycles that last 3 weeks each. Pancreatic tumor vaccine: Vaccine will be administered one day after cyclophosphamide (day 1) every three weeks for 6 cycles. Cyclophosphamide: Cyclophosphamide 250 mg/m2 will be administered one day prior to vaccination (day 0) every three weeks for 6 cycles. None None 12 60 60 60 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infusion reaction, erbitux None General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pruritis, generalized None Skin and subcutaneous tissue disorders None View
Rash None Skin and subcutaneous tissue disorders None View
Diarrhea None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Dizziness None Nervous system disorders None View
Headache None Nervous system disorders None View
Fever None General disorders None View
Lymphopenia None Blood and lymphatic system disorders None View
Hypotension None Cardiac disorders None View
Arthragia None Musculoskeletal and connective tissue disorders None View
Chills None General disorders None View
Fatigue None General disorders None View
Flu like symptoms None General disorders None View
Blisters None Skin and subcutaneous tissue disorders None View
Dry skin None Skin and subcutaneous tissue disorders None View
Erythema, vaccine site None Skin and subcutaneous tissue disorders None View
Induration, vaccine site None Skin and subcutaneous tissue disorders None View
Pruritis, vaccine site None Skin and subcutaneous tissue disorders None View
Tenderness, vaccine site None Skin and subcutaneous tissue disorders None View