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 @ 5:08 PM
Ignite Modification Date: 2025-12-25 @ 2:46 PM
NCT ID: NCT00310050
Description: None
Frequency Threshold: 0
Time Frame: up to 1 year
Study: NCT00310050
Study Brief: Pemetrexed, Gemcitabine, and Radiation Therapy in Treating Patients With 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
Pemetrexed in Combination With Concomitant Radiotherapy Patients will receive Pemetrexed plus Radiotherapy. pemetrexed disodium: 500 milligrams per meter squared day will be given during weeks 1, 3 and 5 of the radiation (3 total doses of Pemetrexed during the radiation therapy). Radiotherapy: During the chemoradiation, the radiotherapy will be administered in 1.8 Gy/fractions after completion of the Pemetrexed infusion, and continue daily (Monday through Friday) for 5 1/2 weeks for a total delivered dose of 50.4 Gy (Total of 28 radiation treatments). 1 None 0 4 2 4 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ALT, SGPT NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Alkaline phosphatase NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Calcium, serum-high NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Calcium, serum-low NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Edema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Edema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) NON_SYSTEMATIC_ASSESSMENT General disorders None View
Gastrointestinal - Other NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Glucose, serum-high NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Glucose, serum-low NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hemoglobin (gender based) NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Infection - Other NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection with normal ANC or Grade 1 or 2 neutrophils NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Leukocytes (total WBC) (4.8-10.8) NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neurology - Other NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neutrophils/granulocytes (ANC/AGC) 1.6-7.3 NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Ocular/Visual - Other NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Pain - Other NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Platelets NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Potassium, serum-high NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Renal/Genitourinary - Other NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Sodium, serum-high NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Watery eye NON_SYSTEMATIC_ASSESSMENT Eye disorders None View