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Table 2 Extent of exposure (safety population)

From: Safety and tolerability of etirinotecan pegol in advanced breast cancer: analysis of the randomized, phase 3 BEACON trial

Endpoint Etirinotecan pegol (n = 425) TPC (n = 406)
Overall exposure duration, days
 Median 48.0 56.5
 Mean (SD) 103.0 ± 117.8 99.5 ± 98.3
Cycles completed, n   
 Median 3.0 3.0
 Mean (SD) 5.5 ± 5.2 5.0 ± 4.2
Relative dose intensity, %a   
 Median 98.3 92.8
 Mean (SD) 92.6 ± 10.7 89.1 ± 16.2
Patient who had any dose reduction, n 117 (27.5 %) 115 (28.3 %)
 Due to AE 117 (27.5 %) 108 (26.6 %)
 Other reason(s) 0 (0.0 %) 9 (2.2 %)
Patients who had any dose delay, n 178 (41.9 %) 190 (46.8 %)
 Due to AE 151 (35.5 %) 150 (36.9 %)
 Other reason(s) 72 (16.9 %) 88 (21.7)
Patients who had any dose interruption, n 18 (4.2 %) 8. (2.0 %)
 Due to AE 15 (3.5 %) 7 (1.7 %)
 Other reason(s) 4 (0.9 %) 1 (0.2 %)
Number of cycles with dose reduction or delay due to AEb 276 (11.8 %) 397 (19.7 %)
  1. AE adverse event, TPC treatment of physician’s choice
  2. aCalculated as dose intensity divided by expected dose intensity; expected dose intensity (mg/m2 per week) equals the assigned dose (mg/m2) divided by planned cycle length (days) times 7
  3. bCalculated as total number of dose reductions or delays due to AE divided by total of number of cycles received