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 @ 2:17 PM
Ignite Modification Date: 2025-12-25 @ 12:54 PM
NCT ID: NCT02775695
Description: None
Frequency Threshold: 0
Time Frame: Each participant was assessed from adverse events up to a maximum of 1 year.
Study: NCT02775695
Study Brief: Efficacy of Doxycycline on Metakaryote Cell Death in Patients With 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
Doxycycline Administered to Patients Patients will receive oral doxycycline and trough serum concentrations for pharmacokinetic studies will be obtained. Doxycycline: Treatment with doxycycline hyclate will be administered as an oral agent on an outpatient basis. Patients will receive doxycycline 100 mg twice daily for a period of 8 weeks (56 days). Upon registration (baseline) and at the first, third, and fifth days of doxycycline therapy, patients will be seen to obtain trough serum concentrations for pharmacokinetic studies. Additional serum levels will be checked on days 8, 15, 22 and 29. 0 None 9 12 11 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaphylaxis SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE 4.03 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.03 View
Gastrointestinal disorders - other, specify SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.03 View
Ascities SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.03 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.03 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.03 View
Gastrointestinal anastomotic leak SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE 4.03 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.03 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ascities SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.03 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.03 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.03 View
Vomitiing SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.03 View
Anaphylaxis SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE 4.03 View
Pancreatic anastomotic leak SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE 4.03 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.03 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.03 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.03 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.03 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.03 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.03 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.03 View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.03 View