Missing 21 (6) Average dose (µg)a 206 (58) µg ≤800 >800-≤1600 µg 54 (15) >1600-≤2400 µg 27 (8) >2400-≤3200 µg 47 (13) >3200 µg 21 (6) Missing 3 (<1) a The average dose per BTP episode and the average daily dose were calculated for the titration and post titration periods combined. BTP=breakthrough pain. Table 21: Average Study Drug Dose per Breakthrough Pain Episode by Weeks or Months of Exposure in Patients with Cancer and Breakthrough Pain. Studies 099-14, 3039, 15. Length of Number (%) of patients by average dose per BTP episode (mcg) exposure <200 Total ≥800 (N=49) (N=18) (N=358) (N=91) (N=100) (N=79) (N=21) day 49 91 100 79 (100) 18 21 358 ≥1 (100) (100) (100) (100) (100) (100) week 27 69 75 79 (100) 17 4 271 (76) ≥1 (55) (76) (75) (94) (19) weeks 19 54 63 74 (94) 16 2 228 (64) ≥2 (39) (59) (63) (89) (10) month 17 35 53 67 (85) 16 1 (5) 189 (53) ≥1 (35) (38) (53) (89) 7 24 38 53 (67) 12 0 134 (37) ≥3 months (14) (26) (38) (67) 3 (6) 15 18 33 (42) 11 0 80 (22) ≥6 months (16) (18) (61)
Missing 21 (6) Average dose (µg)a 206 (58) ≤800 µg >800-≤1600 µg 54 (15) >1600-≤2400 µg 27 (8) >2400-≤3200 µg 47 (13) >3200 µg 21 (6) Missing 3 (<1) a The average dose per BTP episode and the average daily dose were calculated for the titration and post titration periods combined. BTP=breakthrough pain. Table 21: Average Study Drug Dose per Breakthrough Pain Episode by Weeks or Months of Exposure in Patients with Cancer and Breakthrough Pain. Studies 099-14, 3039, Length of exposure Number (%) of patients by average dose per BTP episode (mcg) <200 (N=49) (N=91) (N=100) (N=79) ≥800 (N=18) (N=21) Total (N=358) ≥1 day 49 (100) 91 (100) 100 (100) 79 (100) 18 (100) 21 (100) 358 (100) ≥1 week 27 (55) 69 (76) 75 (75) 79 (100) 17 (94) 4 (19) 271 (76) ≥2 weeks 19 (39) 54 (59) 63 (63) 74 (94) 16 (89) 2 (10) 228 (64) ≥1 month 17 (35) 35 (38) 53 (53) 67 (85) 16 (89) 1 (5) 189 (53) ≥3 months 7 (14) 24 (26) 38 (38) 53 (67) 12 (67) 0 134 (37) ≥6 months 3 (6) 15 (16) 18 (18) 33 (42) 11 (61) 0 80 (22) 15.
auspar-fentanyl-citrate-150422-cer.docx