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