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 @ 12:58 PM
Ignite Modification Date: 2025-12-25 @ 12:18 PM
NCT ID: NCT02658461
Description: Each arm included 12 observations of an episode of care independent of the person being treated. By design of the study, some individuals may have been observed more than once and there may have been fewer than 12 actual participants in each arm.
Frequency Threshold: 0
Time Frame: From arrival to discharge during each episode of care (data collection up to 1 year)
Study: NCT02658461
Study Brief: An Observational Time and Motion Study of Trastuzumab Subcutaneous (SC) and Intravenous (IV) Formulations in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Breast Cancer (EBC)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Trastuzumab Single-Use Injection Device Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling. None None 0 12 0 12 View
Trastuzumab SC Injection Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling. None None 0 12 0 12 View
Trastuzumab IV Infusion Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed \>1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling. None None 0 12 0 12 View
Serious Events(If Any):
Other Events(If Any):