Attribute | Baseline Profiles, % | Baseline Reference and Target Profiles if Tablets Once Every Day Is Preferred to IV Once Every 2 Weeks, % | Baseline Reference and Target Profiles if Intravenous Infusion Once Every 2 Weeks Is Preferred to Tablets Once Every Day, % | |||
---|---|---|---|---|---|---|
Regorafenib | Ramucirumab | Reference Profile (Ramucirumab) | Target Profile (Regorafenib) | Reference Profile (Regorafenib) | Target Profile (Ramucirumab) | |
Risk of hypertension | 25 (31 vs. 6) | 11 (24 vs. 13) | 25 (31 vs. 6) | 11 (24 vs. 13) | 11 (24 vs. 13) | 25 (31 vs. 6) |
Risk of decreased appetite | 16 (31 vs. 15) | 3 (23 vs. 20) | 16 (31 vs. 15) | 3 (23 vs. 20) | 3 (23 vs. 20) | 16 (31 vs. 15) |
Risk of hand-foot skin reaction | 45 (53 vs. 8) | 0 (not reported) | 45 (53 vs. 8) | 0 (not reported) | 0 (not reported) | 45 (53 vs. 8) |
Risk of diarrhea | 26 (41 vs. 15) | 1 (16 vs. 15) | 26 (41 vs. 15) | 1 (16 vs. 15) | 1 (16 vs. 15) | 26 (41 vs. 15) |
Risk of ascites | 0 (16 vs. 16) | 11 (18 vs. 7) | 11 (18 vs. 7) | 0 (16 vs. 16) | 0 (16 vs. 16) | 11 (18 vs. 7) |
Risk of proteinuria | 0 (not reported) | 16 (20 vs. 4) | 16 (20 vs. 4) | 0 (not reported) | 0 (not reported) | 16 (20 vs. 4) |
Risk of peripheral edema | 4 (16 vs. 12) | 11 (25 vs. 14) | 11 (25 vs. 14) | 4 (16 vs. 12) | 4 (16 vs. 12) | 11 (25 vs. 14) |
Mode of administration | Four oral tablets once every day | IV once every 2Â weeks for 30 to 60Â min | Four oral tablets once every day | IV once every 2Â weeks for 30 to 60Â min | Four oral tablets once every day | IV once every 2Â weeks for 30 to 60Â min |