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 @ 5:23 PM
Ignite Modification Date: 2025-12-25 @ 2:58 PM
NCT ID: NCT03093350
Description: Adverse events were assessed starting at the date of 1st injection, then at 1 week after 1st injection, 2 weeks after 1st injection, date of 2nd injection (4 weeks after 1st injection), 1 week after 2nd injection, 2 weeks after 2nd injection, 4 weeks after 2nd injection, and 6 weeks after 2nd injection using descriptions and grading scales found in CTCAE v4.0. All-cause mortality was assessed for 1 year from the date of 1st injection.
Frequency Threshold: 5
Time Frame: 10 weeks (from date of 1st injection up to 6 weeks after date of 2nd injection) for adverse events, and 1 year (from date of 1st injection) for all-cause mortality.
Study: NCT03093350
Study Brief: TACTIC - TAA Specific Cytotoxic T Lymphocytes in Patients With Breast 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
TAA-Specific CTLs Patients receiving TAA-specific CTLs as therapy for breast cancer. TAA-specific CTLs: Each patient will receive 2 injections at a fixed dose, 28 days apart, according to the following dose schedule: The expected volume of infusion will be 1 to 10 cc. Dose schedule: Day 0: 2 x 10\^7 cells/m2 Day 28: 2 x 10\^7 cells/m2 If patients have stable disease or a partial response by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria at their 6 week evaluation after the 2nd cell dose, they will be eligible to receive up to 6 additional doses of CTLs, At least one month should have passed before each additional dose.. Each additional infusion will consist of the same cell number or less (if there is not enough product available for the subject's original dose) than their second infusion. Patients will not be able to receive additional doses until the initial safety profile is completed at 6 weeks following the second infusion. 5 None 1 10 7 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE v4.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v4.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v4.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE v4.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE v4.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.0 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v4.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v4.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v4.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v4.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE v4.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v4.0 View