ADJUVANT SAFETY PROFILE


The APHINITY trial safety profile.

Most common adverse reactions (ARs)

Most common overall ARs (>20%, all grades) in patients receiving PERJETA1

During the targeted treatment-alone phase (following completion of chemotherapy), the only ARs occurring in >10% of patients in the PERJETA treatment group were diarrhea (18%), arthralgia (15%), radiation skin injury (12%), and hot flush (12%).1

Most common >2% severe (Grades 3-4) ARs1

*Denotes an AR that has been reported in association with a fatal outcome.1

Cardiac safety profile1

A substantial decrease in LVEF is defined as a decrease of 10 or more percentage points, to a value <50%.2

Discontinuation rates due to ARs1

Rates of permanent discontinuation of any study therapy due to ARs were1:

  • 13% for patients receiving PERJETA and Herceptin and chemotherapy 
  • 12% for patients receiving placebo and Herceptin and chemotherapy

Diarrhea rates during chemotherapy and after it was discontinued

All grades diarrhea1

Overall incidence of diarrhea was 71% in the PERJETA-treated group and 45% in the placebo-treated group.

Incidence of diarrhea (all grades)1

Grade 2 diarrhea3

Incidence of Grade 2 diarrhea when targeted therapy was administered with chemotherapy:

  • 26% in the PERJETA-treated group
  • 13% in the placebo-treated group

Grades 3-4 diarrhea1,2

Incidence of Grades 3-4 diarrhea1,2

Includes Grade ≥3 ARs with onset from first dose of any study treatment through 28 days after last dose of study treatment.2
Includes Grade ≥3 ARs with onset during the targeted therapy post-chemotherapy treatment period.2

References