Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-25 @ 2:29 PM
NCT ID:
NCT01401166
Group ID:
EG004
Title:
Cohort 1 Overall: SC (SID) and IV Herceptin
Description:
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via SID for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for all cycles where SC Herceptin was given.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
12
Serious Number At Risk:
244
Other Number Affected:
130
Other Number At Risk:
244
Study:
NCT01401166
Results Section:
NCT01401166
Adverse Events Module:
NCT01401166