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 @ 7:47 PM
Ignite Modification Date: 2025-12-25 @ 5:24 PM
NCT ID: NCT02872103
Description: None
Frequency Threshold: 5
Time Frame: AEs and SAEs were collected from the time of randomization until 28 days after completion of the trial (a total of 16 weeks) or 28 days after premature withdrawal of a subject from the trial.
Study: NCT02872103
Study Brief: Placebo-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cycle 1 Placebo Placebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle 1 0 None 10 39 5 39 View
Cycle 1 F-627 F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles. 0 None 4 83 17 83 View
All 4 Cycles F-627 F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles. 0 None 4 83 26 83 View
Cycle 1 Placebo and Cycle 2-4 F-627 Placebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle; and F-627, 20 mg fixed dose pre-filled syringe administered Day 2 of each of the following 3 chemotherapy cycles. 0 None 11 39 9 39 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tumor hemorrhage NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bone pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View