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: 2025-12-26 @ 10:56 AM
Ignite Modification Date: 2025-12-26 @ 10:56 AM
NCT ID: NCT03519308
Description: Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Frequency Threshold: 5
Time Frame: 18 months
Study: NCT03519308
Study Brief: A Pilot Study of Perioperative Nivolumab and Paricalcitol to Target the Microenvironment in Resectable 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
Arm A Nivolumab: Before Surgery Wks 1 \&3, After Surgery Wks 1 \&3 Nab-Paclitaxel: Wks 1,2,3 before surgery and Wks 1, 2,3 after surgery Gemcitabine: Wks 1,2,3 before surgery and Wks 1,2,3 after surgery Paricalcitol: Wks 1,2,3, 4 before surgery and Wks 1,2,3 after surgery 0 None 1 2 2 2 View
Arm B Nivolumab: Before Surgery Wks 1 \&3, After Surgery Wks 1 \&3 Nab-Paclitaxel: Wks 1,2,3 before surgery and Wks 1, 2,3 after surgery Gemcitabine: Wks 1,2,3 before surgery and Wks 1,2,3 after surgery 0 None 1 1 1 1 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hematoma Grade 3 SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Nausea Grade 3 SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain Grade 3 SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anorexia Grade 3 SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rash maculopapular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin infection SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Thrush SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Fatigue SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Cellulitis left arm SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Folliculitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bartholin's gland cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypertriglyceridemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View