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Table 2 Gallbladder Volume (per Independent Review) and Ejection Fraction (per Investigator)

From: The effect of different dosing regimens of motesanib on the gallbladder: a randomized phase 1b study in patients with advanced solid tumors

Endpoint Arm A Arm B Arm C
  Motesanib Motesanib Motesanib
  125 mg QD 75 mg BID 2 wk on/1 wk off 75 mg BID 5 d on/2 d off
  n = 23 n = 11 n = 11
Gallbladder volume, cc (95% CI) n = 23 n = 11 n = 11
 Baseline 33.3 (22.5–44.1) 48.1 (23.1–73.1) 40.2 (14.1–66.2)
 Mean change from baseline 17.7 (6.4–28.9) 26.8 (11.5–42.1) 26.9 (8.8–45.1)
 Maximum change from baseline 45.6 (20.2–70.9) 74.4 (41.3–107.4) 67.3 (30.8–103.8)
Gallbladder ejection fraction, % (95% CI) n = 21 n = 10 n = 10
 Baseline 59.1 (43.5–74.8) 68.7 (50.5–87.0) 58.5 (38.4–78.6)
 Mean change from baseline −24.1 (−38.2 to −9.9) −25.0 (−43.9 to −6.1) −3.3 (−25.0 to 18.4)
 Maximum change from baseline −30.1 (−46.4 to −13.7) −26.5 (−45.0 to −8.0) −6.5 (−29.8 to 16.8)
Reversibility of gallbladder volume changes, cc (95% CI) n = 16 n = 9 n = 8
 Mean change in gallbladder volume after discontinuation of motesanib −8.5 (−38.8 to 21.7) −16.2 (−37.4 to 5.1) −7.4 (−67.1 to 52.4)
 Mean change in gallbladder volume from baseline to last available off- treatment measurement 10.4 (−10.0 to 30.8) −14.4 (−31.1 to 2.4) 7.1 (−28.9 to 43.0)
Reversibility of gallbladder ejection fraction changes, % (95% CI) n = 5 n = 3 n = 2
 Mean change in ejection fraction after discontinuation of motesanib 10.8 (−45.8 to 67.4) 63.0 (24.0 to 102.0) 46.0 (−347.9 to 439.9)
 Mean change in ejection fraction from baseline to last available off- treatment measurement −16.6 (−53.3 to 20.1) 7.7 (−3.8 to 19.1) 14.5 (−55.4 to 84.4)
  1. BID = twice daily; QD = once daily.