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 @ 2:09 PM
Ignite Modification Date: 2025-12-25 @ 12:50 PM
NCT ID: NCT02771795
Description: For any type of serious AE (SAE; cardiac or non-cardiac) that could be determined by the Investigator to be related to the IP then that SAE was reported through a separate paper SAE report form to the Sponsor.
Frequency Threshold: 0
Time Frame: Through end of the study, approximately 4.7 years; Since SB3-G31-BC-E study was to assess the long-term cardiac safety for SB3 or Herceptin®, which was mainly about post-dose cardiac toxicities captured through cardiac assessments, non-serious AEs were not intended to be collected through this study.
Study: NCT02771795
Study Brief: A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Herceptin (Trastuzumab) Intravenous administration Herceptin (trastuzumab): Intravenous administration in SB3-G31-BC study (NCT02149524). No additional IP was administered for this study since it was an observational study. 38 None 1 271 0 271 View
SB3 (Proposed Trastuzumab Biosimilar) Intravenous administration SB3 (proposed trastuzumab biosimilar): Intravenous administration in SB3-G31-BC study (NCT02149524). No additional IP was administered for this study since it was an observational study. 22 None 0 267 0 267 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
cardiac death NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):